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 | Twelve Months | |||||
|
| 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.
| 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 | $ | - | ||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200220005262/en/
Contacts
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
Source: TherapeuticsMD, Inc.
View this news release online at:
http://www.businesswire.com/news/home/20200220005262/en
