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TherapeuticsMD Announces Fourth Quarter and Full-Year 2020 Financial Results

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- Full-year 2020 total net product revenue increased 84% to $62.9 million compared to 2019 -

- 4Q20 total net product revenue increased 30% to $22.6 million compared to 3Q20 -

- ANNOVERA® net product revenue increased 42% for 4Q20 compared to 3Q20 -

- Financing Agreement amended to update minimum net revenue covenants for remainder of loan; Company to pay down $50 million in debt -

- vitaCare divesture progressing with multiple interested parties -

- Conference call scheduled for 8:30 a.m. ET today -

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the full-year and fourth quarter ended December 31, 2020 and provided a business update.

"We delivered a strong year and quarter with record total net product revenue for our Company," said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. "The Company successfully executed on multiple priorities, demonstrating operational agility while maintaining a strict focus on commercial execution and financial discipline. We have lowered our operating expenses, updated our net revenue covenants for the remainder of the term of our loan, and strengthened our balance sheet through a series of equity capital raises and a reduction in our debt." Mr. Finizio continued, "We believe these actions position us well to continue to invest in our products and deliver on our growth objectives."

Fourth Quarter and Full-Year Revenue

Three Months

Ended

December 31,

Three Months

Ended

September 30,

Twelve Months

Ended

December 31,

2020

2019

2020

2020

2019

IMVEXXY

$

8,820,005

$

6,347,301

$

6,841,592

$

27,139,387

$

16,252,045

BIJUVA

2,244,039

1,211,456

1,646,320

6,353,963

1,836,443

ANNOVERA

9,084,074

5,766,604

6,418,990

19,611,286

6,166,556

Prenatal vitamins

2,429,667

2,576,319

2,435,903

9,767,644

9,885,493

License revenue

-

-

2,000,000

2,000,000

15,506,400

Net revenue

$

22,577,785

$

15,901,680

$

19,342,805

$

64,872,280

$

49,646,937

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

  • ANNOVERA net product revenue increased 42% to $9.1 million for the fourth quarter of 2020 as compared to $6.4 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $1,336 for the fourth quarter of 2020.

  • Approximately 6,000 ANNOVERA prescriptions were dispensed during the fourth quarter of 2020. ANNOVERA total prescription volume increased 15% for the fourth quarter of 2020 as compared to the third quarter of 2020. Strong refill rates continued with eligible patients.

IMVEXXY® (estradiol vaginal inserts)

  • IMVEXXY net product revenue increased 29% to $8.8 million for the fourth quarter of 2020 as compared to $6.8 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately $54 for the fourth quarter of 2020. Strong IMVEXXY refill rates continued with patients adhering to therapy.

  • Approximately 123,500 IMVEXXY prescriptions were dispensed during the fourth quarter of 2020. IMVEXXY new prescription volume increased 3% for the fourth quarter of 2020 as compared to the third quarter of 2020, which should positively impact total prescriptions going forward. IMVEXXY total prescriptions declined 6% for the fourth quarter of 2020 as compared to the third quarter of 2020 due to the pandemic.

BIJUVA® (estradiol and progesterone)

  • BIJUVA net product revenue increased 36% to $2.2 million for the fourth quarter of 2020 as compared to $1.6 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately $52 for the fourth quarter of 2020.

  • Approximately 33,000 BIJUVA prescriptions were dispensed in the fourth quarter of 2020. BIJUVA new prescription volume for the fourth quarter of 2020 remained consistent with the third quarter of 2020. Total prescriptions increased 3% during the same period.

Cost of Goods Sold/Gross Margin

  • Cost of goods sold increased $9.6 million to $15.9 million for the full-year 2020 compared to $6.3 million for the full-year 2019. Cost of goods sold increased $2.7 million to $5.6 million for the fourth quarter of 2020 compared to $2.9 million for the fourth quarter of 2019.

  • Cost of goods sold increased $2.3 million to $5.6 million for the fourth quarter of 2020 compared to $3.3 million for the third quarter of 2020.

    • The increase in cost of goods sold as compared to the third quarter is attributable to a 30% increase in product revenue, as well as an increase of $1.7 million in inventory write-downs of ANNOVERA, IMVEXXY and BIJUVA.

  • Gross margin percentage decreased to 75% for the fourth quarter of 2020 as compared to 83% for the third quarter of 2020, primarily as a result of the inventory write-downs recorded in the fourth quarter of 2020.

Expense, EPS and Related Information

  • Total operating expenses for the full-year 2020 increased to $204.4 million compared with $194.5 million for full-year 2019.

  • Total operating expenses for the second half of 2020 were $92.6 million, meeting the Company’s target of $80 million excluding non-cash items and performance-based retention incentives, which totaled $13 million.

  • Total operating expenses for the fourth quarter of 2020 increased by $10.6 million to $51.6 million as compared to $41.0 million for the fourth quarter of 2019.

    • The increase in operating expenses was primarily a result of increased spending focused on delivering the necessary resources to support the launch of ANNOVERA, continued ramp-up of IMVEXXY, and ongoing brand management of BIJUVA.

  • Net loss for the full-year 2020 was $183.5 million, or $0.67 per basic and diluted share, compared with $176.1 million, or $0.72 per basic and diluted share, for full-year 2019. For the fourth quarter of 2020 compared to the prior year period, net loss decreased to $42.1 million, or $0.15 per basic and diluted share, compared with $49.4 million, or $0.19 per basic and diluted share. For the fourth quarter of 2020 compared to the quarter ended September 30, 2020, net loss increased to $42.1 million, or $0.15 per basic and diluted share, compared with $32.6 million, or $0.12 per basic and diluted share.

Balance Sheet

  • As of December 31, 2020, the Company’s cash on hand totaled $80.5 million, compared with $79.6 million as of September 30, 2020.

  • Subsequent to year-end, the Company received approximately $147.9 million in net proceeds from its at-the-market and underwritten equity offerings and repaid $15.0 million in principal under its Financing Agreement, plus a 5% prepayment fee.

Sixth Street Partners Additional Information

  • In connection with the adjustment to the Sixth Street Partners total minimum net revenue covenant, the Company paid down $15 million in principal under its Financing Agreement on March 1, 2021, and agreed to pay down an additional $35 million in principal by the earlier of March 31, 2021 or the closing of the previously announced potential divestiture of the Company’s vitaCare Prescription Services business, in each case plus a 5% prepayment fee. The lenders also consented to a framework for the potential vitaCare disposition.

  • The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA in 2021 is now $17 million, $20 million, $23 million, and $26.5 million for the first, second, third, and fourth quarters, respectively, the first quarter of 2022 is $30 million then increasing by $5 million per quarter thereafter.

  • The Company and the lenders also revised the amortization and prepayment fee schedules under the Financing Agreement to provide for repayments in an aggregate amount of $35 million of principal from the first quarter of 2022 through the first quarter of 2023, with the remaining balance of the loan payable in equal payments over the following four quarters.

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:

Tuesday, March 2, 2021

Time:

8:30 a.m. ET

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

6184646

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 beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 6184646.

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: 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; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; 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; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; 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 volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

December 31,

2020

2019

ASSETS

Current Assets:

Cash

$

80,485,784

$

160,829,713

Accounts receivable, net of allowance for doubtful accounts of $1,117,854 and $904,040, respectively

32,381,701

24,395,958

Inventory, net

7,993,087

11,860,716

Other current assets

7,543,397

11,329,793

Total current assets

128,403,969

208,416,180

Fixed assets, net

1,942,224

2,507,775

Other Assets:

License rights, net

36,196,916

39,221,308

Intangible assets, net

5,247,723

5,258,211

Right of use assets

9,565,700

10,109,154

Other current assets

253,121

473,009

Total other assets

51,263,460

55,061,682

Total assets

$

181,609,653

$

265,985,637

LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY

Current Liabilities:

Accounts payable

$

21,068,327

$

19,181,212

Other current liabilities

38,169,869

33,823,613

Total current liabilities

59,238,196

53,004,825

Long-Term Liabilities:

Long-term debt

237,697,531

194,634,643

Operating lease liability

8,675,477

9,145,049

Total long-term liabilities

246,373,008

203,779,692

Total liabilities

305,611,204

256,784,517

Commitments and Contingencies

Stockholders' (Deficit) Equity:

Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding

-

-

Common stock - par value $0.001; 600,000,000 and 350,000,000 shares authorized: 299,765,396 and 271,177,076 issued and outstanding, respectively

299,765

271,177

Additional paid-in capital

754,644,100

704,351,222

Accumulated deficit

(878,945,416

)

(695,421,279

)

Total stockholders' (deficit) equity

(124,001,551

)

9,201,120

Total liabilities and stockholders' (deficit) equity

$

181,609,653

$

265,985,637

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

Year Ended December 31,

Three Months Ended December 31,

Three Months Ended September 30,

2020

2019

2020

2020

2019

2018

Product revenues, net

$

22,577,785

$

15,901,680

$

17,342,805

$

62,872,280

$

34,140,537

$

16,099,460

License revenue

-

-

2,000,000

2,000,000

15,506,400

-

Total revenue, net

22,577,785

15,901,680

19,342,805

64,872,280

49,646,937

16,099,460

Cost of goods sold

5,580,832

2,878,590

3,278,609

15,974,977

6,334,585

2,737,652

Gross profit

16,996,953

13,023,090

16,064,196

48,897,303

43,312,352

13,361,808

Operating expenses:

Sales, general, and administrative

48,945,068

52,734,093

38,751,250

192,963,967

174,112,612

115,988,954

Research and development

2,393,851

4,432,224

2,027,195

10,431,907

19,792,212

27,299,138

Depreciation and amortization

264,832

248,830

258,787

1,042,170

612,786

293,886

Total operating expenses

51,603,751

57,415,147

41,037,232

204,438,044

194,517,610

143,581,978

Operating loss

(34,606,798

)

(44,392,057

)

(24,973,036

)

(155,540,741

)

(151,205,258

)

(130,220,170

)

Other (expense) income

Loss on extinguishment of debt

-

-

-

-

(10,057,632

)

-

Miscellaneous income

131,902

621,126

41,405

597,647

2,500,106

2,280,844

Interest expense

(7,612,701

)

(5,664,583

)

(7,679,443

)

(28,581,043

)

(17,382,215

)

(4,677,834

)

Total other expense

(7,480,799

)

(5,043,457

)

(7,638,038

)

(27,983,396

)

(24,939,741

)

(2,396,990

)

Loss before income taxes

(42,087,597

)

(49,435,514

)

(32,611,074

)

(183,524,137

)

(176,144,999

)

(132,617,160

)

Provision for income taxes

-

-

-

Net loss

$

(42,087,597

)

$

(49,435,514

)

$

(32,611,074

)

$

(183,524,137

)

$

(176,144,999

)

$

(132,617,160

)

Loss per share, basic and diluted:

Net loss per share, basic and diluted

$

(0.15

)

$

(0.19

)

$

(0.12

)

$

(0.67

)

$

(0.72

)

$

(0.59

)

Weighted average number of common shares outstanding, basic and diluted

286,607,277

261,752,076

272,564,635

275,648,552

246,353,318

225,026,300

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

Year Ended December, 31,

2020

2019

2018

CASH FLOWS FROM OPERATING ACTIVITIES

Net loss

$

(183,524,137

)

$

(176,144,999

)

$

(132,617,160

)

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

Depreciation of fixed assets

772,624

415,193

181,412

Amortization of intangible assets

269,546

197,593

112,474

Write off of patent and trademark cost

1,131,776

78,864

-

Write off of deferred financing fees

275,379

-

-

Non-cash operating lease expense

1,405,443

1,062,318

-

Provision for doubtful accounts

213,814

307,438

216,022

Lease impairment

136,832

.

-

Inventory charge

7,204,818

-

-

Loss on extinguishment of debt

-

10,057,632

-

Share-based compensation

10,678,992

10,693,662

8,661,967

Amortization of intellectual property license fee

3,024,391

778,692

-

Amortization of deferred financing costs

2,256,429

856,302

269,859

Changes in operating assets and liabilities:

Accounts receivable

(8,199,558

)

(13,639,575

)

(6,951,041

)

Inventory

(3,337,189

)

(8,593,046

)

(1,782,312

)

Other assets

3,429,443

(1,880,048

)

(2,657,190

)

Accounts payable

1,887,115

(3,562,629

)

18,646,241

Accrued expenses and other liabilities

2,903,947

13,675,008

9,107,947

Net cash used in operating activities

(159,470,335

)

(165,697,595

)

(106,811,781

)

CASH FLOWS FROM INVESTING ACTIVITIES

Payment for intellectual property license

-

(20,000,000

)

(20,000,000

)

Patent costs

(1,390,834

)

(1,441,989

)

(1,105,407

)

Purchase of fixed assets

(207,073

)

(2,450,285

)

(217,040

)

Payment of security deposit

-

(20,420

)

(175,410

)

Net cash used in investing activities

(1,597,907

)

(23,912,694

)

(21,497,857

)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from exercise of options and warrants

271,678

108,656

1,666,208

Proceeds from sale of common stock, net of costs

31,702,635

77,031,258

89,907,797

Proceeds from Financing Agreement

50,000,000

200,000,000

-

Proceeds from Credit Agreement

-

-

75,000,000

Payment of deferred financing fees

(1,250,000

)

(6,652,270

)

(3,786,918

)

Repayment of Credit Agreement

-

(81,660,719

)

-

Net cash provided by financing activities

80,724,313

188,826,925

162,787,087

(Decrease) increase in cash

(80,343,929

)

(783,364

)

34,477,449

Cash, beginning of period

160,829,713

161,613,077

127,135,628

Cash, end of period

$

80,485,784

$

160,829,713

$

161,613,077

Supplemental disclosure of cash flow information

Interest paid

$

25,849,236

$

17,787,903

$

1,890,166

Non-cash investing activity

Warrant granted in relation to Financing Agreement

$

7,668,161

$

-

$

-

View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005416/en/

Contacts

Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com