Business Wire | Mar 2, 2021 07:00AM EST

TherapeuticsMD Announces Fourth Quarter and Full-Year 2020 Financial Results

Mar. 02, 2021

BOCA RATON, Fla.--(BUSINESS WIRE)--Mar. 02, 2021--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 Three Months Twelve Months

Ended Ended Ended

December 31, September December 31, 30,

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 2,429,667 2,576,319 2,435,903 9,767,644 9,885,493vitamins

License - - 2,000,000 2,000,000 15,506,400revenue

Net $ 22,577,785 $ 15,901,680 $ 19,342,805 $ 64,872,280 $ 49,646,937revenue

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(r) (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(r) (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:

* 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: 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(r), ANNOVERA(r), and BIJUVA(r) 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 32,381,701 24,395,958 doubtful accounts of $1,117,854 and$904,040, respectivelyInventory, 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 sharesissued and outstandingCommon stock - par value $0.001;600,000,000 and 350,000,000 shares 299,765 271,177 authorized: 299,765,396 and 271,177,076issued and outstanding, respectivelyAdditional 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' $ 181,609,653 $ 265,985,637 (deficit) equity

THERAPEUTICSMD, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONSYear 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, net22,577,785

15,901,680

19,342,805

64,872,280

49,646,937

16,099,460

Cost of goods sold5,580,832

2,878,590

3,278,609

15,974,977

6,334,585

2,737,652

Gross profit16,996,953

13,023,090

16,064,196

48,897,303

43,312,352

13,361,808

Operating expenses:Sales, general, and administrative48,945,068

52,734,093

38,751,250

192,963,967

174,112,612

115,988,954

Research and development2,393,851

4,432,224

2,027,195

10,431,907

19,792,212

27,299,138

Depreciation and amortization264,832

248,830

258,787

1,042,170

612,786

293,886

Total operating expenses51,603,751

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) incomeLoss on extinguishment of debt-

-

-

-

(10,057,632

)

-

Miscellaneous income131,902

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 diluted286,607,277

261,752,076

272,564,635

275,648,552

246,353,318

225,026,300

THERAPEUTICSMD, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS Three Months Three Months Ended December 31, Ended September Year Ended December 31, 30, 2020 2019 2020 2020 2019 2018

Product $ 22,577,785 $ 15,901,680 $ 17,342,805 $ 62,872,280 $ 34,140,537 $ 16,099,460 revenues, netLicense revenue - - 2,000,000 2,000,000 15,506,400 -

Total revenue, 22,577,785 15,901,680 19,342,805 64,872,280 49,646,937 16,099,460 net Cost of goods 5,580,832 2,878,590 3,278,609 15,974,977 6,334,585 2,737,652 sold Gross profit 16,996,953 13,023,090 16,064,196 48,897,303 43,312,352 13,361,808

Operatingexpenses:Sales, general, 48,945,068 52,734,093 38,751,250 192,963,967 174,112,612 115,988,954 andadministrativeResearch and 2,393,851 4,432,224 2,027,195 10,431,907 19,792,212 27,299,138 developmentDepreciation 264,832 248,830 258,787 1,042,170 612,786 293,886 andamortizationTotal operating 51,603,751 57,415,147 41,037,232 204,438,044 194,517,610 143,581,978 expenses Operating loss (34,606,798 ) (44,392,057 ) (24,973,036 ) (155,540,741 ) (151,205,258 ) (130,220,170 )

Other (expense)incomeLoss on - - - - (10,057,632 ) - extinguishmentof debtMiscellaneous 131,902 621,126 41,405 597,647 2,500,106 2,280,844 incomeInterest (7,612,701 ) (5,664,583 ) (7,679,443 ) (28,581,043 ) (17,382,215 ) (4,677,834 )expenseTotal other (7,480,799 ) (5,043,457 ) (7,638,038 ) (27,983,396 ) (24,939,741 ) (2,396,990 )expense Loss before (42,087,597 ) (49,435,514 ) (32,611,074 ) (183,524,137 ) (176,144,999 ) (132,617,160 )income taxes 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 anddiluted: Net loss per $ (0.15 ) $ (0.19 ) $ (0.12 ) $ (0.67 ) $ (0.72 ) $ (0.59 )share, basicand diluted Weightedaverage numberof common 286,607,277 261,752,076 272,564,635 275,648,552 246,353,318 225,026,300 sharesoutstanding,basic anddiluted THERAPEUTICSMD, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWSYear Ended December, 31,2020

2019

2018

CASH FLOWS FROM OPERATING ACTIVITIESNet 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 assets772,624

415,193

181,412

Amortization of intangible assets269,546

197,593

112,474

Write off of patent and trademark cost1,131,776

78,864

-

Write off of deferred financing fees275,379

-

-

Non-cash operating lease expense1,405,443

1,062,318

-

Provision for doubtful accounts213,814

307,438

216,022

Lease impairment136,832

.-

Inventory charge7,204,818

-

-

Loss on extinguishment of debt-

10,057,632

-

Share-based compensation10,678,992

10,693,662

8,661,967

Amortization of intellectual property license fee3,024,391

778,692

-

Amortization of deferred financing costs2,256,429

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 assets3,429,443

(1,880,048

)

(2,657,190

)

Accounts payable1,887,115

(3,562,629

)

18,646,241

Accrued expenses and other liabilities2,903,947

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 ACTIVITIESPayment 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 ACTIVITIESProceeds from exercise of options and warrants271,678

108,656

1,666,208

Proceeds from sale of common stock, net of costs31,702,635

77,031,258

89,907,797

Proceeds from Financing Agreement50,000,000

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 activities80,724,313

188,826,925

162,787,087

(Decrease) increase in cash(80,343,929

)

(783,364

)

34,477,449

Cash, beginning of period160,829,713

161,613,077

127,135,628

Cash, end of period$

80,485,784

$

160,829,713

$

161,613,077

Supplemental disclosure of cash flow informationInterest paid$

25,849,236

$

17,787,903

$

1,890,166

Non-cash investing activityWarrant granted in relation to Financing Agreement$

7,668,161

$

-

$

-

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

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