TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

TherapeuticsMD® Announces Second Quarter 2020 Financial Results

 

- 2Q20 total net product revenue of $10.7 million resilient despite COVID-19 pandemic -

- ANNOVERA® prescriptions increased approximately 100% for the eight weeks ended July 24, 2020 over the previous eight week period

-

- IMVEXXY® new prescriptions increased 33% for the eight weeks ended July 24, 2020 over the previous eight week period-

- Consumer campaign for ANNOVERA achieved over 3 million unique views in first 30 days -

- Initial consumer marketing campaign for IMVEXXY to be launched in August -

- Amended Sixth Street Partners revenue covenants to reflect impact of COVID-19 pandemic -

- Conference call scheduled for 8:30 a.m. ET today -

 

BOCA RATON, Fla. August 6, 2020 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the second quarter ended June 30, 2020.

 

“Our organization made significant progress in the second quarter while navigating the COVID-19 pandemic and its impact on our business,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “We delivered a strong quarter of operational execution during very unique circumstances, quickly reducing our operating expenses, reorienting our sales force, and addressing our credit facility future minimum net revenue covenants. These strategic and operational changes and our reshaped Board of Directors and management team are focused on driving revenue and achieving our goal of reaching EBITDA break even in 2021, which we believe will result in long-term shareholder value.”

 

Recent Updates

 

Prescription volume for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) for the eight weeks ended July 24, 2020 increased approximately 100% over the previous eight weeks (the time period most heavily impacted by COVID-19). ANNOVERA current prescription trend exceeds the product’s pre-COVID-19 launch trajectory.
The Company initiated the direct-to-consumer marketing campaign for ANNOVERA on July 1, 2020. Digital metrics show that the “Unapologetically ANNOVERA” campaign has quickly gained visibility resulting in over 100 million impressions and 3 million unique views since launch.
The Company is working with the Department of Defense, public health organizations, and telehealth platforms to expand access to women and contribute to the Company’s growth in the second half of the year.
As of July 1, 2020, ANNOVERA achieved 79% commercial coverage and 46% Medicaid coverage. The vast majority of patients are covered without a copay.
IMVEXXY (estradiol vaginal inserts) new prescriptions for the eight weeks ended July 24, 2020 increased 33% over the previous eight weeks ended May 29, 2020 (the time period most heavily impacted by COVID-19). IMVEXXY continues to experience strong refill rates. These trends should positively impact total prescriptions going forward.
The Company plans to launch the consumer marketing campaign for IMVEXXY during August 2020.
IMVEXXY’s commercial market access is 72% unrestricted commercial coverage, including all of the top ten commercial payors of VVA products. The Company added Wellcare as a Medicare Part D payor.
As of July 1, 2020, BIJUVA® (estradiol and progesterone) capsules commercial market access increased to 73% unrestricted commercial coverage with nine of the top ten commercial payors.

 

Sixth Street Update

 

The Company worked with Sixth Street Partners (“Sixth Street”) to adjust the total minimum net revenue covenant in its financing agreement to reflect the impact of COVID-19. The covenants begin with the results for the fourth quarter of 2020.

 

 

 

 

The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA was adjusted to $20 million for the fourth quarter of 2020. In 2021, the minimum net revenue covenant will be $25 million, $37.5 million, $47.5 million, and $57.5 million for the first, second, third, and fourth quarters, respectively. Given the Company’s current rate of growth, the Company believes it is well positioned to meet or exceed these minimum covenants.
The Company and Sixth Street are not moving forward with the undrawn $50 million tranche under the financing agreement, which was designed to be drawn following the successful full commercial launch of ANNOVERA in the second quarter, due to the pause in the launch timing caused by the COVID-19 pandemic. There continues to be an active dialogue with Sixth Street regarding potential additional financing.

 

Second Quarter Highlights

Net product revenue for the second quarter of 2020 was $10.7 million.
The COVID-19 pandemic had a significant impact on the Company’s product revenue early in the second quarter of 2020. The Company’s products returned to growth mid to late quarter. Notwithstanding COVID-19, the Company expects continued growth in the second half of 2020.
In the second quarter 2020, ANNOVERA net revenue was $1.8 million. Approximately 2,400 ANNOVERA prescriptions were dispensed. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was $1,332.
In the second quarter 2020, IMVEXXY net revenue was $5.1 million. Approximately 118,000 IMVEXXY prescriptions were dispensed. Net revenue per unit was $41. Strong IMVEXXY refill rates continued with patients adhering to therapy.
In the second quarter 2020, BIJUVA net revenue was $1.4 million. Approximately 27,600 BIJUVA prescriptions were dispensed. Net revenue per unit was $45 for the second quarter of 2020.

 

Net Product Revenue

 

   

Three Months Ended

June 30, 2020

   

Three Months Ended

June 30, 2019

 

Three Months Ended

March 31, 2020

 
ANNOVERA    $ 1,835,460     $   2,272,761  
IMVEXXY     5,085,190       3,121,711     6,392,601  
BIJUVA     1,352,001       134,282     1,111,604  
Prenatal vitamins     2,428,382       2,822,872     2,473,691  
Net revenue   $ 10,701,033     $ 6,078,865   $ 12,250,657  

 

Net product revenue for the second quarter of 2020 was affected by the COVID-19 pandemic across all of our products.

 

Cost of Goods Sold/Gross Margin

 

Cost of goods sold increased $1.7 million for the second quarter of 2020 compared to the first quarter of 2020, as the result of a non-cash write-off of $1.9 million primarily related to BIJUVA inventory obsolescence, partially offset by the impact of an overall decline in unit sales. The charge is the result of the Company’s reprioritization of selling resources to ANNOVERA and IMVEXXY along with the impact of the COVID-19 pandemic on sales forecasts of BIJUVA for future quarters. This charge caused gross margin percentage to decline from 78% for the quarter ended March 31, 2020 to 59% for the quarter ended June 30, 2020.

 

Expense, EPS and Related Information

 

Total operating expenses decreased by $9.2 million to $51.3 million for the second quarter of 2020 as compared to $60.5 million for the first quarter of 2020. The decrease in operating expenses was primarily a result of the Company’s cost containment and spend-rebalancing efforts to reduce overall spend in the remaining quarters of the 2020 fiscal year. For the remainder of 2020, spend will focus on delivering the necessary resources to support the launch of ANNOVERA, continued ramp-up of IMVEXXY, and ongoing brand management of BIJUVA. The second quarter of 2020 was impacted by $3.9 million in charges related to product samples expense as a result of the Company’s decision to reduce sampling of BIJUVA.

 

 

 

 

Net loss for the quarter ended June 30, 2020 decreased to $52.0 million, or $0.19 per basic and diluted share, compared with $56.8 million, or $0.21 per basic and diluted share, for the quarter ended March 31, 2020. Net loss per share for the second quarter of 2020 was impacted by inventory and sample expense charges related primarily to BIJUVA of $0.02 per basic and diluted share.

 

Balance Sheet

 

As of June 30, 2020, the Company’s cash on hand totaled $113.8 million, compared with $170.1 million on March 31, 2020. The decline in cash was due primarily to the net loss for the quarter ended June 30, 2020, less certain non-cash items, as well as the timing of advertising, marketing, and social media campaigns for ANNOVERA that were incurred at the end of the quarter ended March 31, 2020 and funded early in the quarter ended June 30, 2020. Total outstanding debt, net of issuance costs, was $243.8 million as of June 30, 2020, compared to $243.4 million as of March 31, 2020. The change is due to the amortization of debt discount of $400,000.

 

Sixth Street Additional Information

In connection with the adjustment to the Sixth Street total minimum net revenue covenant and in lieu of a cash amendment fee, the Company issued to the Sixth Street lenders warrants to purchase an aggregate of approximately 4.75 million shares of the Company’s common stock with an exercise price of $1.58 per share and a ten year term. The warrants are unregistered, do not have registration rights, and do not have anti-dilution protection, other than for customary stock splits and similar transactions.
The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA in 2022 will be $65 million, $75 million, $85 million, and $95 million for the first, second, third, and fourth quarters, respectively, and will remain at $95 million for subsequent 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: Thursday, August 6, 2020
Time: 8:30 a.m. ET
Telephone Access (US): 866-665-9531
Telephone Access (International):          724-987-6977
Access Code for All Callers: 2963048

 

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: 2963048.

 

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

 

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

 

 

 

 

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; 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 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. 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

 

   June 30, 2020   December 31, 2019 
   (Unaudited)     
         
ASSETS    
Current Assets:          
Cash  $113,839,234   $160,829,713 
Accounts receivable, net of allowance for doubtful accounts of $722,240 and $904,040, respectively   18,290,784    24,395,958 
Inventory, net   10,172,312    11,860,716 
Other current assets   6,641,587    11,329,793 
     Total current assets   148,943,917    208,416,180 
           
Fixed assets, net   2,145,926    2,507,775 
           
Other Assets:          
License rights, net   37,721,695    39,221,308 
Intangible assets, net   5,942,873    5,258,211 
Right of use assets   10,337,577    10,109,154 
Other assets   446,925    473,009 
     Total other assets   54,449,070    55,061,682 
       Total assets  $205,538,913   $265,985,637 
           
 LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY          
Current Liabilities:          
Accounts payable  $17,270,319   $19,181,212 
Other current liabilities   29,213,411    33,823,613 
     Total current liabilities   46,483,730    53,004,825 
           
Long-Term Liabilities:          
Long-term debt   243,801,705    194,634,643 
Operating lease liability   9,307,361    9,145,049 
Other long-term liabilities   35,000     
     Total long-term liabilities   253,144,066    203,779,692 
       Total liabilities   299,627,796    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; 272,294,380 and 271,177,076 issued and outstanding, respectively   272,294    271,177 
Additional paid-in capital   709,885,568    704,351,222 
Accumulated deficit   (804,246,745)   (695,421,279)
     Total stockholders’ (deficit) equity   (94,088,883)   9,201,120 
       Total liabilities and stockholders’ equity  $205,538,913   $265,985,637 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended   Three Months Ended   Six Months Ended  
   June 30,   March 31,   June 30,  
   2020   2019   2020   2020   2019 
                     
Product revenue, net  $10,701,033   $6,078,865   $12,250,657   $22,951,690   $10,025,516 
                          
Cost of goods sold   4,400,485    1,248,860    2,715,051    7,115,536    2,011,687 
                          
Gross profit   6,300,548    4,830,005    9,535,606    15,836,154    8,013,829 
                          
Operating expenses:                         
Sales, general, and administrative   48,340,628    41,387,451    56,927,021    105,267,649    76,251,533 
Research and development   2,742,032    4,964,368    3,268,829    6,010,861    11,282,250 
Depreciation and amortization   256,557    115,059    261,994    518,551    221,997 
     Total operating expenses   51,339,217    46,466,878    60,457,844    111,797,061    87,755,780 
                          
Operating loss   (45,038,669)   (41,636,873)   (50,922,238)   (95,960,907)   (79,741,951)
                          
Other (expense) income                         
Loss on extinguishment of debt       (10,057,632)           (10,057,632)
Miscellaneous income   88,858    486,597    335,482    424,340    1,175,318 
Interest expense   (7,026,853)   (4,028,609)   (6,262,046)   (13,288,899)   (6,118,627)
     Total other expense   (6,937,995)   (13,599,644)   (5,926,564)   (12,864,559)   (15,000,941)
                          
Loss before income taxes   (51,976,664)   (55,236,517)   (56,848,802)   (108,825,466)   (94,742,892)
                          
Provision for income taxes                    
                          
Net loss  $(51,976,664)  $(55,236,517)  $(56,848,802)  $(108,825,466)  $(94,742,892)
                          
Loss per share, basic and diluted:                         
                          
Net loss per share, basic and diluted  $(0.19)  $(0.23)  $(0.21)  $(0.40)  $(0.39)
                          
Weighted average number of common                         
  shares outstanding, basic and diluted   271,876,238    241,221,840    271,459,522    271,667,879    241,114,532 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Six Months Ended  
   June 30,  
   2020   2019 
         
CASH FLOWS FROM OPERATING ACTIVITIES          
  Net loss  $(108,825,466)  $(94,742,892)
     Adjustments to reconcile net loss to net cash used in operating activities:          
          Depreciation of fixed assets   387,649    133,049 
          Amortization of intangible assets   130,902    88,948 
          Write off of patent and trademark costs       78,864 
          Operating lease impairment   81,309     
          Non-cash operating lease expense   689,089    443,734 
          (Recovery of) provision for doubtful accounts   (181,800)   167,500 
          Inventory obsolesence reserve   5,965,139     
          Loss on extinguishment of debt       10,057,632 
          Share-based compensation   5,369,279    5,224,212 
          Amortization of deferred financing fees   692,442    316,880 
          Amortization of license fee   1,499,613     
          Changes in operating assets and liabilities:          
             Accounts receivable   6,286,974    (7,486,691)
             Inventory   (4,276,735)   (4,226,770)
             Other current assets   4,412,827    1,710,697 
             Accounts payable   (1,910,893)   (3,244,603)
             Accrued expenses and other current liabilities   (5,420,628)   2,801,717 
           
Net cash used in operating activities   (95,100,299)   (88,677,723)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
  Patent costs   (815,564)   (763,247)
  Purchase of fixed assets   (25,800)   (1,092,504)
  Security deposit   35,000    (20,420)
           
Net cash used in investing activities   (806,364)   (1,876,171)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
  Proceeds from exercise of options and warrants   166,184    100,107 
  Repayment of the Credit Agreement       (81,660,719)
  Proceeds from the Financing Agreement   50,000,000    200,000,000 
  Payment of deferred financing fees   (1,250,000)   (6,652,270)
           
Net cash provided by financing activities   48,916,184    111,787,118 
           
Increase (decrease) in cash   (46,990,479)   21,233,224 
Cash, beginning of period   160,829,713    161,613,077 
Cash, end of period  $113,839,234   $182,846,301 
           
Supplemental disclosure of cash flow information          
           
Interest paid  $12,032,014   $6,989,570 

 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Thursday, August 6, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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