TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

TherapeuticsMD Announces Fourth Quarter and Full-Year 2020 Financial Results

 

- 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. March 2, 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

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.

 

 

 
 

 

IMVEXXYâ (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.

 

BIJUVAÒ (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.
oThe 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.
oThe 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®, 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.

# # #

 

Investor Contact

Nichol Ochsner

Vice President, Investor Relations

561-961-1900, ext. 2088

Nochsner@TherapeuticsMD.com

 

 

 

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 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Tuesday, March 2, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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