- 4Q19 Total Net Product Revenue of
- Full-Year 2019 Total Net Product Revenue of
- Company Launched ANNOVERA, a Novel, Long-Lasting Contraceptive -
- Company Expects Full-Year 2020 Net Product Revenue of
- Conference Call Scheduled for
“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
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 throughDecember 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. AdditionalMedicare 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
|
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
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
Expense, EPS and Related Information
Research and development (R&D) expenses for the full-year 2019 decreased to
Sales, general and administrative (SG&A) expenses for the full-year 2019 increased to
Net loss for the full-year 2019 was
Balance Sheet
As of
Total outstanding debt, net of issuance costs, was approximately
On
2020 Financial Guidance
The company projects that product net revenue for 2020 will be between
Conference Call and Webcast Details
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
Please see the Full Prescribing Information, including indication and Boxed WARNING, for each
- 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. 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/
Source:
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com