BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.
“We are very pleased with our results for the quarter, which are in-line with our financial guidance, and reaffirm our fourth quarter 2019 financial guidance,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “This reiterates our confidence that we will be able to access an additional $50 million in capital from our term loan facility when fourth quarter 2019 results are announced. Additionally, we recently completed an equity raise that netted the company approximately $77 million and improved our liquidity. We believe we now have the resources and momentum to continue to fully execute our plans into 2020 and beyond.”
Third Quarter and Recent Developments
- IMVEXXY® (estradiol vaginal inserts) third quarter 2019 product net revenue increased by 53% to approximately $4.8 million and prescriptions dispensed and paid for by patients increased 26% to approximately 134,000 as compared to the second quarter of 2019. Strong refill rates continued with patients adhering to therapy at an average rate of four fills per year through September 2019.
- IMVEXXY has market access for the majority of lives under commercial plans with approximately 68% unrestricted commercial access. IMVEXXY is now covered by eight of the ten top commercial payers of vulvar and vaginal atrophy (VVA) products. A ninth top-ten commercial payer will adjudicate beginning in January 2020. Two of the top six Medicare Part D payers of VVA products cover IMVEXXY and additional Medicare coverage decisions are expected by the end of 2019.
- BIJUVA® (estradiol and progesterone) capsules third quarter 2019 product net revenue and prescriptions increased two-fold to approximately $0.5 million and approximately 15,800 prescriptions dispensed and paid for by patients during the third quarter as compared to the second quarter of 2019.
- BIJUVA currently has approximately 55% unrestricted commercial access and is covered by six of the top ten commercial payers.
- ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) generated third quarter product net revenue of approximately $0.4 million. The company is in the “test and learn” market introduction phase of launch for ANNOVERA, the first and only long-lasting, patient-controlled, procedure-free, reversible prescription contraceptive option for women.
- ANNOVERA has already achieved approximately 62% unrestricted commercial access and is covered by six of the top ten commercial payers by commercial payer lives.
- On October 29, 2019, the company received net proceeds of approximately $77.0 million from an underwritten public offering of its common stock to support commercialization efforts for its three FDA-approved products and to maximize ANNOVERA’s consumer-focused commercialization strategy.
Summary of Third Quarter 2019 Financial Results
Total net revenue increased to approximately $23.7 million, for the third quarter of 2019 compared with net revenue of approximately $3.5 million for the prior year’s quarter. During the third quarter of 2019, the company recognized license revenue of approximately $15.5 million from the upfront fee, a non-refundable payment, under the company’s license agreement with Theramex, which is included in total revenue for the quarter.
Product net revenue increased to approximately $8.2 million, for the three months ended September 30, 2019 compared with approximately $3.5 million for the three months ended September 30, 2018. Product net revenue increased primarily due to increases in sales of approximately $4.5 million of IMVEXXY in the current period, partially offset by a decrease in prenatal vitamin sales of approximately $0.7 million. Product net revenue for the three months ended September 2019 also included sales of BIJUVA of approximately $0.5 million and sales of ANNOVERA of approximately $0.4 million. The revenue decrease related to our prenatal vitamins was primarily affected by a lower number of units sold as compared to the prior year period, partially offset by increased revenue per unit. The company launched IMVEXXY in the third quarter of 2018, BIJUVA in the second quarter of 2019, and ANNOVERA in the third quarter of 2019.
The following table provides information about disaggregated revenue by product mix for the three months ended September 30, 2019 and 2018:
|
Three Months
|
||
|
2019 |
|
2018 |
Prenatal vitamins |
$2,550,330 |
|
$3,261,459 |
IMVEXXY |
4,772,354 |
|
212,076 |
BIJUVA |
490,705 |
|
- |
ANNOVERA |
399,952 |
|
- |
License revenue |
15,506,400 |
|
- |
Net revenue |
$23,719,741 |
|
$3,473,535 |
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. We expect our product revenues to improve as commercial and Medicare payer coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at pharmacies.
Research and development (R&D) expenses for the third quarter of 2019 decreased to approximately $4.1 million, compared with approximately $6.7 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 increased for the third quarter of 2019 to approximately $45.1 million, compared with approximately $30.4 million for the prior year’s quarter. The increase of SG&A expenses for third 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.
For the third quarter of 2019, net loss decreased to approximately $32.0 million, or $0.13 per basic and diluted share, compared with approximately $35.6 million, or $0.16 per basic and diluted share, for the third quarter of 2018.
Balance Sheet
As of September 30, 2019, the company’s cash on hand totaled approximately $155.3 million, compared with approximately $161.6 million at December 31, 2018. On October 29, 2019, the company received net proceeds of approximately $77.0 million from an underwritten public offering of its common stock.
Total outstanding debt, net of issuance costs, was approximately $194.4 million as of September 30, 2019.
Financial Guidance
The company reaffirms its previously announced fourth quarter 2019 financial guidance outlined below:
- FDA-approved product net revenue is expected to be in a range of $11 million to $13 million;
- Prescription prenatal vitamin net revenue is expected to be in a range of $1.75 million to $2.25 million; and
- Total product net revenue is expected to be in a range of $12.75 million to $15.25 million.
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: |
Wednesday, November 6, 2019 |
Time: |
4:30 p.m. ET |
Telephone Access (US): |
866-665-9531 |
Telephone Access (International): |
724-987-6977 |
Access Code for All Callers: |
7045719 |
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: 7045719.
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, Inc.
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 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 additional tranches thereunder; 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 ability of the company’s licensees to commercialize and distribute the company’s products; 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 | ||||
| September 30, 2019 | December 31, 2018 | |||
| (Unaudited) | ||||
| ASSETS | ||||
| Current Assets: | ||||
| Cash | $ 155,330,050 |
$ 161,613,077 |
||
| Accounts receivable, net of allowance for doubtful accounts | ||||
| of $691,699 and $596,602, respectively | 15,323,614 |
11,063,821 |
||
| Inventory | 10,532,844 |
3,267,670 |
||
| Other current assets | 10,578,260 |
10,834,693 |
||
| Total current assets | 191,764,768 |
186,779,261 |
||
| Fixed assets, net | 2,338,346 |
472,683 |
||
| Other Assets: | ||||
| License rights, net | 39,984,002 |
20,000,000 |
||
| Intangible assets, net | 4,942,151 |
4,092,679 |
||
| Right-of-use asset | 10,459,635 |
|
||
| Other assets | 473,009 |
639,301 |
||
| Total other assets | 55,858,797 |
24,731,980 |
||
| Total assets | $ 249,961,911 |
$ 211,983,924 |
||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
| Current Liabilities: | ||||
| Accounts payable | $ 24,133,506 |
$ 22,743,841 |
||
| Other current liabilities | 43,196,032 |
18,334,948 |
||
| Total current liabilities | 67,329,538 |
41,078,789 |
||
| Long-Term Liabilities: | ||||
| Long-term debt | 194,361,169 |
73,381,014 |
||
| Operating lease liability | 9,500,133 |
- |
||
| Total liabilities | 271,190,840 |
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: | ||||
| 241,277,076 and 240,462,439 issued and outstanding, respectively | 241,277 |
240,463 |
||
| Additional paid-in capital | 624,515,559 |
616,559,938 |
||
| Accumulated deficit | (645,985,765) |
(519,276,280) |
||
| Total stockholders' (deficit) equity | (21,228,929) |
97,524,121 |
||
| Total liabilities and stockholders' equity | $ 249,961,911 |
$ 211,983,924 |
||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (Unaudited) | |||||||
| Three Months Ended | Nine Months Ended | ||||||
| September 30, | September 30, | ||||||
2019 |
|
2018 |
|
2019 |
|
2018 |
|
| Product revenue, net | $ 8,213,341 |
$ 3,473,535 |
$ 18,238,857 |
$ 11,009,937 |
|||
| License revenue | 15,506,400 |
- |
15,506,400 |
- |
|||
| Total revenue, net | 23,719,741 |
3,473,535 |
33,745,257 |
11,009,937 |
|||
| Cost of goods sold | 1,444,308 |
699,118 |
3,455,995 |
1,786,902 |
|||
| Gross profit | 22,275,433 |
2,774,417 |
30,289,262 |
9,223,035 |
|||
| Operating expenses: | |||||||
| Sales, general, and administrative | 45,126,986 |
30,354,072 |
121,378,519 |
80,578,079 |
|||
| Research and development | 4,077,738 |
6,708,271 |
15,359,988 |
20,545,948 |
|||
| Depreciation and amortization | 141,959 |
73,321 |
363,956 |
198,545 |
|||
| Total operating expenses | 49,346,683 |
37,135,664 |
137,102,463 |
101,322,572 |
|||
| Operating loss | (27,071,250) |
(34,361,247) |
(106,813,201) |
(92,099,537) |
|||
| Other expense | |||||||
| Loss on extinguishment of debt | - |
- |
(10,057,632) |
- |
|||
| Miscellaneous income | 703,662 |
809,022 |
1,878,980 |
1,457,817 |
|||
| Interest expense | (5,599,005) |
(2,053,077) |
(11,717,632) |
(2,584,459) |
|||
| Total other expense | (4,895,343) |
(1,244,055) |
(19,896,284) |
(1,126,642) |
|||
| Loss before income taxes | (31,966,593) |
(35,605,302) |
(126,709,485) |
(93,226,179) |
|||
| Provision for income taxes | - |
- |
- |
- |
|||
| Net loss | $ (31,966,593) |
$ (35,605,302) |
$ (126,709,485) |
$ (93,226,179) |
|||
| Loss per share, basic and diluted: | |||||||
| Net loss per share, basic and diluted | $ (0.13) |
$ (0.16) |
$ (0.53) |
$ (0.42) |
|||
| Weighted average number of common | |||||||
| shares outstanding, basic and diluted | 241,261,299 |
228,107,240 |
241,163,994 |
220,466,673 |
|||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
| (Unaudited) | |||||||
| Nine Months Ended | |||||||
| September 30, | |||||||
|
2019 |
|
|
2018 |
|
||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
| Net loss | $ |
(126,709,485 |
) |
$ |
(93,226,179 |
) |
|
| Adjustments to reconcile net loss to net cash used in | |||||||
| operating activities: | |||||||
| Depreciation of fixed assets |
|
223,750 |
|
|
121,423 |
|
|
| Amortization of intangible assets |
|
140,206 |
|
|
77,123 |
|
|
| Write off of patent and trademark cost |
|
78,864 |
|
|
- |
|
|
| Non-cash operating lease expense |
|
711,836 |
|
|
- |
|
|
| Provision for doubtful accounts |
|
95,097 |
|
|
231,475 |
|
|
| Loss on extinguishment of debt |
|
10,057,632 |
|
|
- |
|
|
| Share-based compensation |
|
7,859,357 |
|
|
6,388,635 |
|
|
| Amortization of intellectual property license fee |
|
15,998 |
|
|
- |
|
|
| Amortization of deferred financing fees |
|
582,829 |
|
|
149,909 |
|
|
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable |
|
(4,354,890 |
) |
|
(8,705,325 |
) |
|
| Inventory |
|
(7,265,174 |
) |
|
(892,863 |
) |
|
| Other current assets |
|
(1,128,515 |
) |
|
1,233,482 |
|
|
| Accounts payable |
|
1,389,665 |
|
|
7,284,493 |
|
|
| Accrued expenses and other liabilities |
|
3,402,511 |
|
|
8,670,986 |
|
|
| Net cash used in operating activities |
|
(114,900,319 |
) |
|
(78,666,841 |
) |
|
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
| Payment for intellectual property license |
|
- |
|
|
(20,000,000 |
) |
|
| Patent costs |
|
(1,068,542 |
) |
|
(748,906 |
) |
|
| Purchase of fixed assets |
|
(2,089,413 |
) |
|
(66,295 |
) |
|
| Payment of security deposit |
|
(20,420 |
) |
|
(11,485 |
) |
|
| Net cash used in investing activities |
|
(3,178,375 |
) |
|
(20,826,686 |
) |
|
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
| Proceeds from Financing Agreement |
|
200,000,000 |
|
|
- |
|
|
| Proceeds from exercise of options and warrants |
|
108,656 |
|
|
1,236,313 |
|
|
| Proceeds from sale of common stock, net of costs |
|
- |
|
|
89,907,797 |
|
|
| 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 |
|
111,795,667 |
|
|
162,357,192 |
|
|
| (Decrease) increase in cash |
|
(6,283,027 |
) |
|
62,863,665 |
|
|
| Cash, beginning of period |
|
161,613,077 |
|
|
127,135,628 |
|
|
| Cash, end of period | $ |
155,330,050 |
|
$ |
189,999,293 |
|
|
| Supplemental disclosure of cash flow information | |||||||
| Interest paid | $ |
12,446,792 |
|
$ |
1,759,316 |
|
|
| Non-cash investing activity | |||||||
| Amount accrued for intellectual property license | $ |
20,000,000 |
|
$ |
- |
|
|
