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TherapeuticsMD Announces Fourth Quarter and Full-Year 2020 Financial Results

March 2, 2021 7:00 AM EST

- 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 -

BOCA RATON, Fla.--(BUSINESS WIRE)-- 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

 

 

$

-

 

 

$

-

 

       

 

Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
[email protected]

Source: TherapeuticsMD, Inc.



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