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 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

                         
   Three Months Ended
December 31,
   Three Months Ended
September 30,
    Year Ended
December 31,
 
   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 differences made from one to another to evaluate Therapeuticsmd, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Therapeuticsmd, Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account