THERAPEUTICSMD, INC. 8-K

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces First Quarter 2018 Financial Results

 

- $200 Million Non-Dilutive Term Loan Financing Completed to Support Commercialization -

 

- PDUFA target action date of May 29, 2018 for TX-004HR -

 

- PDUFA target action date of October 28, 2018 for TX-001HR -

 

BOCA RATON, Fla. May 3, 2018TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced its financial results for the quarter ended March 31, 2018.

 

First Quarter and Recent Developments

 

Entered into a definitive loan agreement with MidCap Financial, managed by Apollo Capital Management, L.P., for $200 million in non-dilutive term loan financing. The term loan will be available to the company in three tranches following specific milestones through December 31, 2019: $75 million will be available upon the approval of TX-004HR, $75 million will be available upon the approval and launch of TX-001HR, and $50 million will be available upon certain sales milestones in calendar year 2019, in each case subject to certain terms and conditions. The term loan will accrue interest at 1-month LIBOR plus 7.75%, subject to a LIBOR floor of 1.50%. Interest on amounts borrowed under the term loan will be payable monthly in arrears; principal on each tranche borrowed under the term loan will be payable in 36 equal monthly installments beginning May 1, 2020, subject to the company’s ability to extend the interest-only period by an additional 12 months if the company generates certain revenues with respect to TX-004HR and TX-001HR. The maturity date is May 1, 2023.
Entered into negotiations with the U.S. Food and Drug Administration (FDA) regarding the proposed label for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, in April 2018. The PDUFA target action date for the completion of the FDA's review of the NDA is May 29, 2018.
Submitted the NDA for TX-001HR, the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause, on December 28, 2017. The FDA in its 74-day letter stated that the application was sufficiently complete to permit a substantive review and that, at such time, the FDA had not identified any potential review issues. The PDUFA target action date for the completion of the FDA's review of the NDA is October 28, 2018.
Net revenue for the company’s prescription prenatal vitamin business was approximately $3.8 million for the first quarter of 2018, compared with approximately $4.0 million for the first quarter of 2017.
Net loss was approximately $24.4 million for the first quarter of 2018, compared with approximately $21.2 million for the first quarter of 2017.
Ended the quarter with approximately $107.3 million in cash and no debt.
Grew the company’s intellectual property portfolio to a current total of 216 patent filings, including 126 international filings, with one allowed and 19 issued U.S. patents.

 

“Our company has tremendous opportunity in the coming year,” said TherapeuticsMD CEO Robert G. Finizio. “We have the potential for approvals of both of our late-stage product candidates in 2018, representing major inflection points for our company.”

 

   
 

 

Summary of First Quarter 2018 Financial Results

 

Net revenue from the company’s prescription prenatal vitamin business was approximately $3.8 million for the first quarter of 2018 compared with net revenue of approximately $4.0 million for the prior year’s quarter. These changes were primarily due to a decrease in the average net sales price of the company’s products, partially offset by an increase in the number of units sold.

 

Cost of goods sold was approximately $0.6 million for the first quarter of 2018, compared with approximately $0.7 million for the prior year’s quarter.

 

Total operating expenses for the first quarter of 2018 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the first quarter of 2018 were approximately $7.0 million compared with approximately $7.7 million for the prior year’s quarter. The decrease in R&D was a direct result of the completion of the Replenish Trial for TX-001HR. SG&A expenses for the first quarter of 2018 were approximately $20.8 million compared with approximately $16.8 million for the prior year’s quarter, primarily due to higher sales, marketing, and personnel costs to support future commercialization.

 

Net loss for the first quarter of 2018 was approximately $24.4 million, or $0.11 per basic and diluted share, compared with approximately $21.2 million, or $0.11 per basic and diluted share, for the first quarter of 2017.

 

At March 31, 2018, cash on hand was approximately $107.3 million, compared with approximately $127.1 million at December 31, 2017.

 

Additional information regarding the company’s loan agreement with MidCap Financial is available in the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission today. Cowen acted as lead arranger and financial advisor to TherapeuticsMD with respect to the MidCap Financial transaction and Oppenheimer & Co. acted as co-financial advisor in the transaction.

 

 

Conference Call Today

 

As previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business update. Details for the call are:

 

Date: Thursday, May 3, 2018

Time: 4:30 p.m. EST

Telephone Access (US): 866-665-9531

Telephone Access (International): 724-987-6977

Access Code for All Callers: 9196916

 

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the Home Page or under the “Investors & Media” section. 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: 9196916.

 

   
 

 

About TherapeuticsMD, Inc.

 

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The Company’s late stage clinical pipeline includes two product candidates that have completed phase 3 trials and are awaiting approval by the FDA: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The Company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

 

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 resolve the deficiencies identified by the FDA in the company’s new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the FDA will approve the amended NDA for the company’s TX-004HR product candidate and whether such approval will occur by the PDUFA target action date; whether the FDA will approve the NDA for the company’s TX-001HR product candidate and whether such approval will occur by the PDUFA target action date; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company be able to comply with the covenants and conditions under its term loan agreement; the length, cost and uncertain results of the company’s clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; 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

 

David DeLucia

Director, Investor Relations

561-961-1900
David.DeLucia@TherapeuticsMD.com

 

   
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

      March 31, 2018       December 31, 2017  
      (Unaudited)          
ASSETS
Current Assets:                
Cash   $ 107,349,460     $ 127,135,628  
Accounts receivable, net of allowance for doubtful accounts of $403,535 and $380,580, respectively     5,096,731       4,328,802  
Inventory     1,620,872       1,485,358  
Other current assets     5,098,132       6,604,284  
Total current assets     119,165,195       139,554,072  
                 
Fixed assets, net     425,539       437,055  
                 
Other Assets:                
Intangible assets, net     3,220,686       3,099,747  
Security deposit     150,522       139,036  
Total other assets     3,371,208       3,238,783  
Total assets   $ 122,961,942     $ 143,229,910  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:                
Accounts payable   $ 6,283,824     $ 4,097,600  
Other current liabilities     9,375,818       9,223,595  
Total current liabilities     15,659,642       13,321,195  
                 
                 
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: 216,584,274 and 216,429,642 issued and outstanding, respectively     216,584       216,430  
Additional paid-in capital     518,146,665       516,351,405  
Accumulated deficit     (411,060,949)       (386,659,120)  
Total stockholders' equity     107,302,300       129,908,715  
Total liabilities and stockholders' equity   $ 122,961,942     $ 143,229,910  

 

 

   
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited) 

 

     Three Months Ended  
      March 31, 2018       March 31, 2017  
                 
Revenues, net   $ 3,773,392     $ 3,985,464  
                 
Cost of goods sold     633,623       659,635  
                 
Gross profit     3,139,769       3,325,829  
                 
Operating expenses:                
Sales, general, and administrative     20,757,237       16,837,617  
Research and development     7,039,297       7,724,840  
Depreciation and amortization     59,621       49,699  
                 
Total operating expenses     27,856,155       24,612,156  
                 
Operating loss     (24,716,386 )     (21,286,327 )
                 
Other income                
Miscellaneous income     314,557       125,968  
Accreted interest           3,867  
                 
Total other income     314,557       129,835  
                 
Loss before income taxes     (24,401,829 )     (21,156,492)  
                 
Provision for income taxes            
                 
Net loss    $ (24,401,829 )   $ (21,156,492 )
                 
Loss per share, basic and diluted:                
                 
Net loss per share, basic and diluted   $ (0.11 )   $ (0.11 )
                 
Weighted average number of common shares outstanding, basic and diluted     216,525,316       197,790,040  

 

   
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited) 

 

     Three Months Ended  
      March 31, 2018       March 31, 2017  
CASH FLOWS FROM OPERATING ACTIVITIES                
Net loss   $ (24,401,829 )   $ (21,156,492 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation     38,424       33,600  
Amortization of intangible assets     21,197       16,099  
Provision for (recovery of) doubtful accounts     22,955       (1,603 )
Share-based compensation     1,751,358       1,413,195  
Changes in operating assets and liabilities:                
Accounts receivable     (790,885 )     580,943  
Inventory     (135,514 )     (262,297 )
Other current assets     1,506,152       (253,518 )
Accounts payable     2,186,224       (1,212,236 )
Other current liabilities     152,223       316,638  
                 
Net cash used in operating activities     (19,649,695 )     (20,525,671 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Patent costs     (142,136 )     (107,487 )
Purchase of fixed assets     (26,908 )     (27,834 )
Payment of security deposit     (11,486 )     —   
                 
Net cash used in investing activities     (180,530 )     (135,321 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from exercise of options     44,057       192,310  
Proceeds from exercise of warrants     —        2,460,000  
                 
Net cash provided by financing activities     44,057       2,652,310  
                 
Decrease in cash     (19,786,168 )     (18,008,682 )
Cash, beginning of period     127,135,628       131,534,101  
Cash, end of period   $ 107,349,460     $ 113,525,419  

 

   

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Thursday, May 3, 2018 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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