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TherapeuticsMD Announces Fourth Quarter and Full-Year 2018 Financial Results

February 21, 2019 4:05 PM

Successful Launch of IMVEXXY®, Strong Positive

Trends Continue for Prescriptions and Patient Refills

BIJUVA™ Commercial Launch on Track for the Second Quarter of 2019

ANNOVERA™ Commercial Launch planned as Early as the Third Quarter of 2019

Conference Call Scheduled for 4:30 p.m. ET Today

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced its commercial and corporate update for the fourth quarter and full-year ended December 31, 2018.

“In 2018, we completed our most successful year to date and transformed into a leading women’s healthcare company,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “As we begin 2019, we are focused on executing the next phases of our commercialization strategy. IMVEXXY continues to deliver strong growth in prescriptions and in patient refill activity. Its success has laid the foundation for the upcoming launches of BIJUVA in the second quarter of this year and ANNOVERA as early as the third quarter of this year. We are enthusiastic about expanding our BIO-IGNITESM program with our compounding pharmacy partners that represent a large and important channel for physicians and patients in hormone therapy.”

IMVEXXY Launch Continues to Highlight Successful Launch Execution

Key Expected Events in 2019

Summary of Fourth Quarter and Full Year 2018 Financial Results

For the year ended December 31, 2018, net revenues were approximately $16.1 million compared with approximately $16.8 million for the prior year. Net revenues for the fourth quarter of 2018 were approximately $5.1 million compared with net revenues of approximately $4.1 million for the prior year’s quarter. Net revenues from the company’s prescription prenatal vitamin business were approximately $4.2 million for the fourth quarter of 2018, compared with approximately $4.1 million for the fourth quarter of 2017. Net revenues for IMVEXXY for the fourth quarter of 2018 were approximately $0.9 million and were greatly affected by our co-pay assistance program introduced to launch IMVEXXY, which is a maximum $35 out-of-pocket copay assistance program that allows eligible patients to access the product for a reasonable cost regardless of the insurance coverage. The decrease in full-year 2018 net revenues related to lower prenatal vitamins revenues of approximately $1.6 million, primarily due to a lower number of units sold and higher utilization of coupons offered to customers in 2018 as compared to the prior year, partially offset by approximately $1.1 million in net revenues for IMVEXXY. Net revenues for IMVEXXY were greatly affected by our co-pay assistance program. The company expects the net revenues for IMVEXXY to improve as commercial payer coverage for IMVEXXY increases and insurance plans complete the process needed to adjudicate IMVEXXY prescriptions at pharmacies.

Research and development (R&D) expenses for the full-year 2018 decreased to approximately $27.3 million, compared with approximately $33.9 for the prior year. R&D expenses for the fourth quarter of 2018 were approximately $6.8 million compared with approximately $11.0 million for the prior year’s quarter. The decrease in full-year 2018 R&D expenses was primarily as a result of the completion of the REPLENISH Trial for BIJUVA and FDA approval of IMVEXXY and BIJUVA, partially offset by scale-up and manufacturing activities for BIJUVA before FDA approval as well as increased pre-clinical work to support our product pipeline.

Sales, general and administrative (SG&A) expenses for the full-year 2018 increased to approximately $116.0 million, compared with approximately $57.7 million for the prior year. SG&A expenses for the fourth quarter of 2018 were approximately $35.4 million compared with approximately $14.2 million for the prior year’s quarter. The increase in full-year 2018 sales and marketing expenses was primarily a result of increased expenses associated with sales and marketing efforts to support launch and commercialization of IMVEXXY and BIJUVA, including costs related to outsourced sales personnel and their related expenses, physician education and product samples, 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, prepares for the launch of ANNOVERA and continues to support its growing business and commercialization of its products.

Net loss for the full-year 2018 was approximately $132.6 million, or $0.59 per basic and diluted share, compared with approximately $76.9 million, or $0.37 per basic and diluted share, for the full-year of 2017. Net loss for the fourth quarter of 2018 was approximately $39.4 million, or $0.17 per basic and diluted share, compared with approximately $21.4 million, or $0.10 per basic and diluted share, for the fourth quarter of 2017.

Balance Sheet

As of December 31, 2018, the company’s cash on hand totaled approximately $161.6 million, compared with approximately $127.1 million at December 31, 2017. Total outstanding debt, net of issuance costs, was approximately $73.4 million as of December 31, 2018.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and audio webcast today, at 4:30 p.m. ET to discuss these financial results and provide a business update.

Date: Thursday, February 21, 2019

Time: 4:30 p.m. ET

Telephone Access (US): 866-665-9531

Telephone Access (International): 724-987-6977

Access Code for All Callers: 3494187

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: 3494187.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:

About�TherapeuticsMD, Inc.

TherapeuticsMD, Inc.�is an innovative 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 company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERATM, BIJUVATM 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 agreement; 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; 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 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.

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
� � � � �
December 31,
� 2018 � � 2017 �
ASSETS
Current Assets:
Cash $ 161,613,077 $ 127,135,628
Accounts receivable, net of allowance for doubtful accounts
of $596,602 and $380,580, respectively 11,063,821 4,328,802
Inventory 3,267,670 1,485,358
Other current assets � 10,834,693 � � 6,604,284 �
Total current assets � 186,779,261 � � 139,554,072 �
�
Fixed assets, net � 472,683 � � 437,055 �
�
Other Assets:
License rights 20,000,000 -
Intangible assets, net 4,092,679 3,099,747
Other assets 324,855 -
Security deposit � 314,446 � � 139,036 �
Total other assets � 24,731,980 � � 3,238,783 �
Total assets $ 211,983,924 � $ 143,229,910 �
�
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 22,743,841 $ 4,097,600
Accrued expenses and other current liabilities � 18,334,948 � � 9,223,595 �
Total current liabilities � 41,078,789 � � 13,321,195 �
�
Long-Term Liabilities:
Long-term debt � 73,381,014 � � - �
Total liabilities � 114,459,803 � � 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:
240,462,439 and 216,429,642 issued and outstanding, respectively 240,463 216,430
Additional paid-in capital 616,559,938 516,351,405
Accumulated deficit � (519,276,280 ) � (386,659,120 )
Total stockholders' equity � 97,524,121 � � 129,908,715 �
Total liabilities and stockholders' equity $ 211,983,924 � $ 143,229,910 �
�
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
�
� � Three Months Ended December 31, Year Ended December 31,
� � � � � � � �
� 2018 � � � 2017 � � 2018 � � � 2017 � � � 2016 �
�
�
Revenues, net $ 5,089,523 $ 4,124,218 $ 16,099,460 $ 16,777,713 $ 19,356,450
�
Cost of goods sold � 950,750 � � 594,769 � � 2,737,652 � � 2,636,943 � � 4,185,708 �
�
Gross profit � 4,138,773 � � 3,529,449 � � 13,361,808 � � 14,140,770 � � 15,170,742 �
�
Operating expenses:
Sales, general, and administrative 35,410,875 14,178,958 115,988,954 57,703,370 51,348,414
Research and development 6,753,190 10,974,956 27,299,138 33,852,993 53,943,477
Depreciation and amortization � 95,341 � � 56,174 � � 293,886 � � 213,117 � � 132,451 �
Total operating expenses � 42,259,406 � � 25,210,088 � � 143,581,978 � � 91,769,480 � � 105,424,342 �
�
Operating loss � (38,120,633 ) � (21,680,639 ) � (130,220,170 ) � (77,628,710 ) � (90,253,600 )
�
Other (expense) income
Miscellaneous income 823,027 253,309 2,280,844 695,631 367,317
Interest expense (2,093,375 ) - (4,677,834 ) - -
Accreted interest - - - 7,699 10,824
� � � � �
Total other (expense) income � (1,270,348 ) � 253,309 � � (2,396,990 ) � 703,330 � � 378,141 �
�
Loss before income taxes (39,390,981 ) (21,427,330 ) (132,617,160 ) (76,925,380 ) (89,875,459 )
�
Provision for income taxes � - � � - � � - � � - � � - �
�
Net loss $ (39,390,981 ) $ (21,427,330 ) $ (132,617,160 ) $ (76,925,380 ) $ (89,875,459 )
�
Loss per share, basic and diluted:
�
Net loss per share, basic and diluted $ (0.17 ) $ (0.10 ) $ (0.59 ) $ (0.37 ) $ (0.46 )
�
Weighted average number of common
shares outstanding, basic and diluted � 238,556,492 � � 216,429,642 � � 225,026,300 � � 205,523,288 � � 196,088,196 �
�
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
�
�
� � � � Year Ended December, 31,
� 2018 � � � 2017 � � � 2016 �
�
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (132,617,160 ) $ (76,925,380 ) $ (89,875,459 )
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation of fixed assets 181,412 141,601 77,906
Amortization of intangible assets 112,474 71,516 54,545
Provision for doubtful accounts 216,022 4,206 2,524,909
Share-based compensation 8,661,967 6,889,323 17,411,021
Amortization of deferred financing costs 269,859 - -
Changes in operating assets and liabilities:
Accounts receivable (6,951,041 ) 167,691 (3,975,893 )
Inventory (1,782,312 ) (409,037 ) (386,168 )
Other current assets (2,332,335 ) (4,434,130 ) 709,907
Other assets (324,855 ) - -
Accounts payable 18,646,241 (3,260,914 ) 4,232,340
Accrued expenses and other current liabilities 9,107,947 1,599,510 84,559
� � �
�
Net cash used in operating activities � (106,811,781 ) � (76,155,614 ) � (69,142,333 )
�
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license (20,000,000 ) - -
Patent costs (1,105,407 ) (765,291 ) (845,266 )
Purchase of fixed assets (217,040 ) (61,817 ) (396,154 )
Payment of security deposit (175,410 ) - (14,036 )
� � �
�
Net cash used in investing activities � (21,497,857 ) � (827,108 ) � (1,255,456 )
�
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs 89,907,797 68,572,635 134,863,475
Proceeds from term loan 75,000,000 - -
Payment of deferred financing fees (3,786,918 ) - -
Proceeds from exercise of options 1,666,208 212,615 989,060
Proceeds from exercise of warrants - 3,798,999 1,373,000
� � �
�
Net cash provided by financing activities � 162,787,087 � � 72,584,249 � � 137,225,535 �
�
Increase (decrease) in cash 34,477,449 (4,398,473 ) 66,827,746
Cash, beginning of period � 127,135,628 � � 131,534,101 � � 64,706,355 �
Cash, end of period $ 161,613,077 � $ 127,135,628 � $ 131,534,101 �
�
Supplemental disclosure of cash flow information
Interest paid $ 1,890,166 $ - $ -
�

Investor Contact

Nichol Ochsner,

Vice President Investor Relations

561-961-1900, ext. 2088

[email protected]

Source: TherapeuticsMD, Inc.

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