TherapeuticsMD Inc. 8-K

 

Exhibit 99.1

 

 

 

 

FOR IMMEDIATE RELEASE

 

TherapeuticsMD Announces Fourth Quarter and Full-Year 2019 Financial Results

 

- 4Q19 Total Net Product Revenue of $15.9 Million Exceeded the Company’s Financial Guidance-

- Full-Year 2019 Total Net Product Revenue of $34.1 Million at the Top End of Financial Guidance-

-Company Launched ANNOVERA, a Novel, Long-Lasting Contraceptive-

- Company Expects Full-Year 2020 Net Product Revenue of $90 Million to $110 Million -

 

- Conference Call Scheduled for 8:30 a.m. ET Today -

 

BOCA RATON, Fla.  February 20, 2020 – 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, 2019 and provided 2020 financial guidance.

 

“I am very pleased with our commercial team’s execution in 2019, which has put us in a strong position for 2020. We ended the year exceeding our fourth quarter net revenue guidance and achieved the top end of our full-year guidance,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “Our goal is to build on this momentum as we make additional investments in our products to generate a significant revenue inflection point in 2020.”

 

Fourth Quarter & Recent Highlights

 

Net product revenue for the fourth quarter of 2019 increased 94% to $15.9 million compared to the third quarter of 2019.

 

ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) achieved net revenue of $5.8 million for the fourth quarter of 2019 from sales to wholesalers and pharmacies with an average net revenue per unit of approximately $1,350.

 

ANNOVERA has already achieved market access for the majority of lives under commercial plans with 75% commercial coverage.

 

IMVEXXY® (estradiol vaginal inserts) fourth quarter 2019 net revenue increased by 33% to $6.3 million compared to the third quarter of 2019. In the fourth quarter of 2019, approximately 123,000 IMVEXXY prescriptions were dispensed and paid for by patients. Average calculated net revenue per unit was approximately $51 for the fourth quarter of 2019. Strong IMVEXXY refill rates continued with patients adhering to therapy at an average rate of 4.4 fills through December 2019. Those patients on IMEXXY for one year averaged over six fills.

 

IMVEXXY has market access for the majority of lives under commercial plans with 72% unrestricted commercial coverage. IMVEXXY is now covered by all of the top ten commercial payors of vulvar and vaginal atrophy (VVA) products. Three of the top six Medicare Part D payors of VVA products cover IMVEXXY. Additional Medicare coverage is expected when the 2020 decisions are made for this class of products.

 

BIJUVA® (estradiol and progesterone) capsules fourth quarter 2019 net revenue increased 147% to $1.2 million compared to the third quarter of 2019. In the fourth quarter of 2019, approximately 22,000 prescriptions were dispensed and paid for by patients. Average calculated net revenue per unit was $56 for the fourth quarter of 2019.

 

BIJUVA has market access for the majority of lives under commercial plans with 56% commercial coverage. BIJUVA is covered by seven of the top ten commercial payors of vasomotor symptoms (VMS) products.

 

 

 

Fourth Quarter and Full-Year Revenue Performance

For the year ended December 31, 2019, net product revenue increased 112% to $34.1 million compared to $16.1 million for the prior year. Net product revenue for the fourth quarter of 2019 increased 94% to $15.9 million compared to $5.1 million for the prior year’s quarter.

 

 

 

Three Months
 Ended
December 31,

 

 

Twelve Months
Ended
December 31,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

 

 

 

 

(in thousands)

 

 

 

 

                                 

Prenatal vitamins

 

$

2,576,319

 

 

$

4,243,398

 

 

$

9,885,493

 

 

$

15,041,259

 

IMVEXXY

 

 

6,347,301

 

 

 

846,125

 

 

 

16,252,045

 

 

 

1,058,201

 

BIJUVA

 

 

1,211,456

 

 

 

 

 

 

1,836,443

 

 

 

 

ANNOVERA

 

 

5,766,604

 

 

 

 

 

 

6,166,556

 

 

 

 

License revenue

 

 

 

 

 

 

 

 

15,506,400

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue

 

$

15,901,680

 

 

$

5,089,523

 

 

$

49,646,937

 

 

$

16,099,460

 

 

Net product revenue increased primarily due to an increase in sales of $15.2 million of IMVEXXY for the year ended December 31, 2019, partially offset by a decrease in prenatal vitamin sales of $5.2 million. Product revenue for the year ended December 31, 2019 also included sales of BIJUVA of $1.8 million and sales of ANNOVERA of $6.2 million. The decrease in revenue related to our prenatal vitamins was primarily affected by a lower number of units sold as compared to the prior year period.

 

Net revenue for IMVEXXY and BIJUVA has been greatly affected by the company’s co-pay assistance programs introduced to provide products at a reasonable cost regardless of insurance coverage. The company expects net product revenue to improve as commercial and Medicare payor coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at pharmacies.

 

Expense, EPS and Related Information

Research and development (R&D) expenses for the full-year 2019 decreased to $19.8 million, compared with $27.3 million for the prior year. R&D expenses for the fourth quarter of 2019 were $4.4 million compared with $6.8 million for the prior year’s quarter. R&D costs decreased primarily as a result of transferring certain costs and activities from R&D expenses to operations as they begin to support commercial and launch efforts after the FDA approval of IMVEXXY and BIJUVA. R&D expenses include costs related to manufacturing validation as well as early development trials and employment costs of personnel involved in R&D activities.

 

Sales, general and administrative (SG&A) expenses for the full-year 2019 increased to $174.1 million compared with $116.0 million for the prior year. SG&A expenses increased to $52.7 million for the fourth quarter of 2019 compared with $35.4 million for the prior year’s quarter. The increase in SG&A expenses for full-year and fourth quarter 2019 was primarily a result of increased expenses associated with sales and marketing efforts and personnel costs to support the launch and commercialization of IMVEXXY, BIJUVA, and ANNOVERA, including outsourced sales personnel and their related expenses, physician education, advertising, and travel expenses related to product commercialization. The company expects sales and marketing expenses to continue to increase as it continues the launch of BIJUVA and ANNOVERA and continues to support its growing business and commercialization of its products.

 

Net loss for the full-year 2019 was $176.1 million, or $0.72 per basic and diluted share, compared with $132.6 million, or $0.59 per basic and diluted share, for full-year 2018. For the fourth quarter of 2019, net loss increased to $49.4 million, or $0.19 per basic and diluted share, compared with $39.4 million, or $0.17 per basic and diluted share, for the fourth quarter of 2018.

 

 

 

Balance Sheet

As of December 31, 2019, the company’s cash on hand totaled approximately $160.8 million, compared with approximately $161.6 million at December 31, 2018.

 

Total outstanding debt, net of issuance costs, was approximately $194.6 million as of December 31, 2019.

 

On February 18, 2020, the company received the second tranche of funding under its financing agreement with TPG Specialty Lending, Inc. in the amount of $50 million following the company’s achievement of $11 million in net revenues from IMVEXXY, BIJUVA, and ANNOVERA for the fourth quarter of 2019.

 

2020 Financial Guidance

The company projects that product net revenue for 2020 will be between $90 million to $110 million. The company projects that product net revenue during the second half of the year will be significantly larger than the first half with the majority of 2020 product net revenue coming from ANNOVERA and IMVEXXY. The company anticipates high deductible and annual copay resets will impact first quarter of 2020 revenue for its menopause products and expects first quarter 2020 product net revenue to come in below fourth quarter 2019 product net revenue.

 

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:

Thursday, February 20, 2020

Time:

8:30 a.m. ET

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

7359398

 

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: 7359398.

 

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 company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, BIJUVA® and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility, including the conditions to draw an additional tranche thereunder and whether the lender will make such tranche available; 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 efficacy supplement for the lower dose of 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. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

 

# # #

 

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, 
   2019   2018 
ASSETS 
Current Assets:          
Cash  $160,829,713   $161,613,077 
Accounts receivable, net of allowance for doubtful accounts of $904,040 and $596,602, respectively   24,395,958    11,063,821 
Inventory   11,860,716    3,267,670 
Other current assets   11,329,793    10,834,693 
Total current assets   208,416,180    186,779,261 
           
Fixed assets, net   2,507,775    472,683 
           
Other Assets:          
License rights, net   39,221,308    20,000,000 
Intangible assets, net   5,258,211    4,092,679 
Right of use asset   10,109,154     
Other current assets   473,009    639,301 
Total other assets   55,061,682    24,731,980 
Total assets  $265,985,637   $211,983,924 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY 
Current Liabilities:          
Accounts payable  $19,181,212   $22,743,841 
Other current liabilities   33,823,613    18,334,948 
Total current liabilities   53,004,825    41,078,789 
           
Long-Term Liabilities:          
Long-term debt   194,634,643    73,381,014 
Operating lease liability   9,145,049     
Total liabilities   256,784,517    114,459,803 
           
Commitments and Contingencies          
           
Stockholders’ Equity:          
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding        
Common stock - par value $0.001; 350,000,000 shares authorized: 271,177,076 and 240,462,439 issued and outstanding, respectively   271,177    240,463 
Additional paid-in capital   704,351,222    616,559,938 
Accumulated deficit   (695,421,279)   (519,276,280)
Total stockholders’ equity   9,201,120    97,524,121 
Total liabilities and stockholders’ equity  $265,985,637   $211,983,924 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   Three Months Ended December 31,   Year Ended December 31, 
   2019   2018   2019   2018   2017 
                     
Product revenues, net  $15,901,680   $5,089,523   $34,140,537   $16,099,460   $16,777,713 
License revenue           15,506,400         
    15,901,680    5,089,523    49,646,937    16,099,460    16,777,713 
                          
Cost of goods sold   2,878,590    950,750    6,334,585    2,737,652    2,636,943 
                          
Gross profit   13,023,090    4,138,773    43,312,352    13,361,808    14,140,770 
                          
Operating expenses:                         
Sales, general, and administrative   52,734,093    35,410,875    174,112,612    115,988,954    57,703,370 
Research and development   4,432,224    6,753,190    19,792,212    27,299,138    33,852,993 
Depreciation and amortization   248,830    95,341    612,786    293,886    213,117 
Total operating expenses   57,415,147    42,259,406    194,517,610    143,581,978    91,769,480 
                          
Operating loss   (44,392,057)   (38,120,633)   (151,205,258)   (130,220,170)   (77,628,710)
                          
Other (expense) income                         
Loss on extinguishment of debt           (10,057,632)        
Miscellaneous income   621,126    823,027    2,500,106    2,280,844    695,631 
Interest expense   (5,664,583)   (2,093,375)   (17,382,215)   (4,677,834)    
Accreted interest                   7,699 
Total other (expense) income   (5,043,457)   (1,270,348)   (24,939,741)   (2,396,990)   703,330 
                          
Loss before income taxes   (49,435,514)   (39,390,981)   (176,144,999)   (132,617,160)   (76,925,380)
                          
Provision for income taxes                    
                          
Net loss  $(49,435,514)  $(39,390,981)  $(176,144,999)  $(132,617,160)  $(76,925,380)
                          
Loss per share, basic and diluted:                         
                          
Net loss per share, basic and diluted  $(0.19)  $(0.17)  $(0.72)  $(0.59)  $(0.37)
                          
Weighted average number of common shares outstanding, basic and diluted   261,752,076    238,556,492    246,353,318    225,026,300    205,523,288 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Year Ended December, 31, 
   2019   2018   2017 
CASH FLOWS FROM OPERATING ACTIVITIES               
Net loss  $(176,144,999)  $(132,617,160)  $(76,925,380)
Adjustments to reconcile net loss to net cash used in operating activities:               
Depreciation of fixed assets   415,193    181,412    141,601 
Amortization of intangible assets   197,593    112,474    71,516 
Write off of patent and trademark cost   78,864         
Non-cash operating lease expense   1,062,318         
Provision for doubtful accounts   307,438    216,022    4,206 
Loss of extinguishment of debt   10,057,632         
Share-based compensation   10,693,662    8,661,967    6,889,323 
Amortization of intellectual property license fee   778,692         
Amortization of deferred financing costs   856,302    269,859     
Changes in operating assets and liabilities:               
Accounts receivable   (13,639,575)   (6,951,041)   167,691 
Inventory   (8,593,046)   (1,782,312)   (409,037)
Other assets   (1,880,048)   (2,657,190)   (4,434,130)
Accounts payable   (3,562,629)   18,646,241    (3,260,914)
Accrued expenses and other liabilities   13,675,008    9,107,947    1,599,510 
                
Net cash used in operating activities   (165,697,595)   (106,811,781)   (76,155,614)
                
CASH FLOWS FROM INVESTING ACTIVITIES               
Payment for intellectual property license   (20,000,000)   (20,000,000)    
Patent costs   (1,441,989)   (1,105,407)   (765,291)
Purchase of fixed assets   (2,450,285)   (217,040)   (61,817)
Payment of security deposit   (20,420)   (175,410)    
Net cash used in investing activities   (23,912,694)   (21,497,857)   (827,108)
                
CASH FLOWS FROM FINANCING ACTIVITIES               
                
Proceeds from exercise of options and warrants   108,656    1,666,208    4,011,614 
Proceeds from sale of common stock, net of costs   77,031,258    89,907,797    68,572,635 
Proceeds from Financing Agreement   200,000,000         
Proceeds from Credit Agreement       75,000,000     
Payment of deferred financing fees   (6,652,270)   (3,786,918)    
Repayment of Credit Agreement   (81,660,719)        
                
Net cash provided by financing activities   188,826,925    162,787,087    72,584,249 
                
(Decrease) increase in cash   (783,364)   34,477,449    (4,398,473)
Cash, beginning of period   161,613,077    127,135,628    131,534,101 
Cash, end of period  $160,829,713   $161,613,077   $127,135,628 
                
Supplemental disclosure of cash flow information               
Interest paid  $17,787,903   $1,890,166   $ 

 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Thursday, February 20, 2020 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.

View differences made from one year 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 10-K Annual Report 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