- Full-year 2020 total net product revenue increased 84% to
- 4Q20 total net product revenue increased 30% to
- ANNOVERA® net product revenue increased 42% for 4Q20 compared to 3Q20 -
- Financing Agreement amended to update minimum net revenue covenants for remainder of loan; Company to pay down
- vitaCare divesture progressing with multiple interested parties -
- Conference call scheduled for
“We delivered a strong year and quarter with record total net product revenue for our Company,” said
Fourth Quarter and Full-Year Revenue |
|||||||||||||||
|
Three Months Ended |
Three Months Ended |
Twelve Months Ended |
||||||||||||
|
2020 |
2019 |
2020 |
2020 |
2019 |
||||||||||
|
|
||||||||||||||
IMVEXXY |
$ |
8,820,005 |
$ |
6,347,301 |
$ |
6,841,592 |
$ |
27,139,387 |
$ |
16,252,045 |
|||||
BIJUVA |
|
2,244,039 |
|
1,211,456 |
|
1,646,320 |
|
6,353,963 |
|
1,836,443 |
|||||
ANNOVERA |
|
9,084,074 |
|
5,766,604 |
|
6,418,990 |
|
19,611,286 |
|
6,166,556 |
|||||
Prenatal vitamins |
|
2,429,667 |
|
2,576,319 |
|
2,435,903 |
|
9,767,644 |
|
9,885,493 |
|||||
License revenue |
|
- |
|
- |
|
2,000,000 |
|
2,000,000 |
|
15,506,400 |
|||||
Net revenue |
$ |
22,577,785 |
$ |
15,901,680 |
$ |
19,342,805 |
$ |
64,872,280 |
$ |
49,646,937 |
|||||
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
- ANNOVERA net product revenue increased 42% to
$9.1 million for the fourth quarter of 2020 as compared to$6.4 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was$1,336 for the fourth quarter of 2020. - Approximately 6,000 ANNOVERA prescriptions were dispensed during the fourth quarter of 2020. ANNOVERA total prescription volume increased 15% for the fourth quarter of 2020 as compared to the third quarter of 2020. Strong refill rates continued with eligible patients.
IMVEXXY® (estradiol vaginal inserts)
- IMVEXXY net product revenue increased 29% to
$8.8 million for the fourth quarter of 2020 as compared to$6.8 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately$54 for the fourth quarter of 2020. Strong IMVEXXY refill rates continued with patients adhering to therapy. - Approximately 123,500 IMVEXXY prescriptions were dispensed during the fourth quarter of 2020. IMVEXXY new prescription volume increased 3% for the fourth quarter of 2020 as compared to the third quarter of 2020, which should positively impact total prescriptions going forward. IMVEXXY total prescriptions declined 6% for the fourth quarter of 2020 as compared to the third quarter of 2020 due to the pandemic.
BIJUVA® (estradiol and progesterone)
- BIJUVA net product revenue increased 36% to
$2.2 million for the fourth quarter of 2020 as compared to$1.6 million for the third quarter of 2020. Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately$52 for the fourth quarter of 2020. - Approximately 33,000 BIJUVA prescriptions were dispensed in the fourth quarter of 2020. BIJUVA new prescription volume for the fourth quarter of 2020 remained consistent with the third quarter of 2020. Total prescriptions increased 3% during the same period.
Cost of Goods Sold/Gross Margin
- Cost of goods sold increased
$9.6 million to$15.9 million for the full-year 2020 compared to$6.3 million for the full-year 2019. Cost of goods sold increased$2.7 million to$5.6 million for the fourth quarter of 2020 compared to$2.9 million for the fourth quarter of 2019. - Cost of goods sold increased
$2.3 million to$5.6 million for the fourth quarter of 2020 compared to$3.3 million for the third quarter of 2020.- The increase in cost of goods sold as compared to the third quarter is attributable to a 30% increase in product revenue, as well as an increase of
$1.7 million in inventory write-downs of ANNOVERA, IMVEXXY and BIJUVA.
- The increase in cost of goods sold as compared to the third quarter is attributable to a 30% increase in product revenue, as well as an increase of
- Gross margin percentage decreased to 75% for the fourth quarter of 2020 as compared to 83% for the third quarter of 2020, primarily as a result of the inventory write-downs recorded in the fourth quarter of 2020.
Expense, EPS and Related Information
- Total operating expenses for the full-year 2020 increased to
$204.4 million compared with$194.5 million for full-year 2019. - Total operating expenses for the second half of 2020 were
$92.6 million , meeting the Company’s target of$80 million excluding non-cash items and performance-based retention incentives, which totaled$13 million . - Total operating expenses for the fourth quarter of 2020 increased by
$10.6 million to$51.6 million as compared to$41.0 million for the fourth quarter of 2019.- The increase in operating expenses was primarily a result of increased spending focused on delivering the necessary resources to support the launch of ANNOVERA, continued ramp-up of IMVEXXY, and ongoing brand management of BIJUVA.
- Net loss for the full-year 2020 was
$183.5 million , or$0.67 per basic and diluted share, compared with$176.1 million , or$0.72 per basic and diluted share, for full-year 2019. For the fourth quarter of 2020 compared to the prior year period, net loss decreased to$42.1 million , or$0.15 per basic and diluted share, compared with$49.4 million , or$0.19 per basic and diluted share. For the fourth quarter of 2020 compared to the quarter endedSeptember 30, 2020 , net loss increased to$42.1 million , or$0.15 per basic and diluted share, compared with$32.6 million , or$0.12 per basic and diluted share.
Balance Sheet
- As of
December 31, 2020 , the Company’s cash on hand totaled$80.5 million , compared with$79.6 million as ofSeptember 30, 2020 . - Subsequent to year-end, the Company received approximately
$147.9 million in net proceeds from its at-the-market and underwritten equity offerings and repaid$15.0 million in principal under its Financing Agreement, plus a 5% prepayment fee.
Sixth Street Partners Additional Information
- In connection with the adjustment to the
Sixth Street Partners total minimum net revenue covenant, the Company paid down$15 million in principal under its Financing Agreement onMarch 1, 2021 , and agreed to pay down an additional$35 million in principal by the earlier ofMarch 31, 2021 or the closing of the previously announced potential divestiture of the Company’s vitaCare Prescription Services business, in each case plus a 5% prepayment fee. The lenders also consented to a framework for the potential vitaCare disposition. - The total minimum net revenue requirement for ANNOVERA, IMVEXXY, and BIJUVA in 2021 is now
$17 million ,$20 million ,$23 million , and$26.5 million for the first, second, third, and fourth quarters, respectively, the first quarter of 2022 is$30 million then increasing by$5 million per quarter thereafter. - The Company and the lenders also revised the amortization and prepayment fee schedules under the Financing Agreement to provide for repayments in an aggregate amount of
$35 million of principal from the first quarter of 2022 through the first quarter of 2023, with the remaining balance of the loan payable in equal payments over the following four quarters.
Conference Call and Webcast Details
Date: |
|
||
Time: |
|
||
Telephone Access (US): |
866-665-9531 |
||
Telephone Access (International): |
724-987-6977 |
||
Access Code for All Callers: |
6184646 |
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
|
||||||||
CONSOLIDATED BALANCE SHEETS |
||||||||
|
||||||||
2020 |
2019 |
|||||||
ASSETS |
||||||||
Current Assets: |
||||||||
Cash |
$ |
80,485,784 |
|
$ |
160,829,713 |
|
||
Accounts receivable, net of allowance for doubtful accounts of |
|
32,381,701 |
|
|
24,395,958 |
|
||
Inventory, net |
|
7,993,087 |
|
|
11,860,716 |
|
||
Other current assets |
|
7,543,397 |
|
|
11,329,793 |
|
||
Total current assets |
|
128,403,969 |
|
|
208,416,180 |
|
||
Fixed assets, net |
|
1,942,224 |
|
|
2,507,775 |
|
||
Other Assets: |
||||||||
License rights, net |
|
36,196,916 |
|
|
39,221,308 |
|
||
Intangible assets, net |
|
5,247,723 |
|
|
5,258,211 |
|
||
Right of use assets |
|
9,565,700 |
|
|
10,109,154 |
|
||
Other current assets |
253,121 |
473,009 |
||||||
Total other assets |
|
51,263,460 |
|
|
55,061,682 |
|
||
Total assets |
$ |
181,609,653 |
|
$ |
265,985,637 |
|
||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ |
21,068,327 |
|
$ |
19,181,212 |
|
||
Other current liabilities |
|
38,169,869 |
|
|
33,823,613 |
|
||
Total current liabilities |
|
59,238,196 |
|
|
53,004,825 |
|
||
Long-Term Liabilities: |
||||||||
Long-term debt |
|
237,697,531 |
|
|
194,634,643 |
|
||
Operating lease liability |
|
8,675,477 |
|
|
9,145,049 |
|
||
Total long-term liabilities |
|
246,373,008 |
|
|
203,779,692 |
|
||
Total liabilities |
|
305,611,204 |
|
|
256,784,517 |
|
||
Commitments and Contingencies |
||||||||
Stockholders' (Deficit) Equity: |
||||||||
Preferred stock - par value |
|
- |
|
|
- |
|
||
Common stock - par value |
|
299,765 |
|
|
|
271,177 |
|
|
Additional paid-in capital |
|
754,644,100 |
|
|
704,351,222 |
|
||
Accumulated deficit |
|
(878,945,416 |
) |
|
(695,421,279 |
) |
||
Total stockholders' (deficit) equity |
|
(124,001,551 |
) |
|
9,201,120 |
|
||
Total liabilities and stockholders' (deficit) equity |
$ |
181,609,653 |
|
$ |
265,985,637 |
|
||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||||
Year Ended |
||||||||||||||||||||||||
Three Months Ended |
Three Months Ended |
|||||||||||||||||||||||
2020 |
2019 |
2020 |
2020 |
2019 |
2018 |
|||||||||||||||||||
Product revenues, net |
$ |
22,577,785 |
|
$ |
15,901,680 |
|
$ |
17,342,805 |
|
$ |
62,872,280 |
|
$ |
34,140,537 |
|
$ |
16,099,460 |
|
||||||
License revenue |
|
- |
|
|
- |
|
|
2,000,000 |
|
|
2,000,000 |
|
|
15,506,400 |
|
|
- |
|
||||||
Total revenue, net |
|
22,577,785 |
|
|
15,901,680 |
|
|
19,342,805 |
|
|
64,872,280 |
|
|
49,646,937 |
|
|
16,099,460 |
|
||||||
Cost of goods sold |
|
5,580,832 |
|
|
2,878,590 |
|
|
3,278,609 |
|
|
15,974,977 |
|
|
6,334,585 |
|
|
2,737,652 |
|
||||||
Gross profit |
|
16,996,953 |
|
|
13,023,090 |
|
|
16,064,196 |
|
|
48,897,303 |
|
|
43,312,352 |
|
|
13,361,808 |
|
||||||
Operating expenses: | ||||||||||||||||||||||||
Sales, general, and administrative |
|
48,945,068 |
|
|
52,734,093 |
|
|
38,751,250 |
|
|
192,963,967 |
|
|
174,112,612 |
|
|
115,988,954 |
|
||||||
Research and development |
|
2,393,851 |
|
|
4,432,224 |
|
|
2,027,195 |
|
|
10,431,907 |
|
|
19,792,212 |
|
|
27,299,138 |
|
||||||
Depreciation and amortization |
|
264,832 |
|
|
248,830 |
|
|
258,787 |
|
|
1,042,170 |
|
|
612,786 |
|
|
293,886 |
|
||||||
Total operating expenses |
|
51,603,751 |
|
|
57,415,147 |
|
|
41,037,232 |
|
|
204,438,044 |
|
|
194,517,610 |
|
|
143,581,978 |
|
||||||
Operating loss |
|
(34,606,798 |
) |
|
(44,392,057 |
) |
|
(24,973,036 |
) |
|
(155,540,741 |
) |
|
(151,205,258 |
) |
|
(130,220,170 |
) |
||||||
Other (expense) income | ||||||||||||||||||||||||
Loss on extinguishment of debt |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(10,057,632 |
) |
|
- |
|
||||||
Miscellaneous income |
|
131,902 |
|
|
621,126 |
|
|
41,405 |
|
|
597,647 |
|
|
2,500,106 |
|
|
2,280,844 |
|
||||||
Interest expense |
|
(7,612,701 |
) |
|
(5,664,583 |
) |
|
(7,679,443 |
) |
|
(28,581,043 |
) |
|
(17,382,215 |
) |
|
(4,677,834 |
) |
||||||
Total other expense |
|
(7,480,799 |
) |
|
(5,043,457 |
) |
|
(7,638,038 |
) |
|
(27,983,396 |
) |
|
(24,939,741 |
) |
|
(2,396,990 |
) |
||||||
Loss before income taxes |
|
(42,087,597 |
) |
|
(49,435,514 |
) |
|
(32,611,074 |
) |
|
(183,524,137 |
) |
|
(176,144,999 |
) |
|
(132,617,160 |
) |
||||||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|||||||||||||||
Net loss |
$ |
(42,087,597 |
) |
$ |
(49,435,514 |
) |
$ |
(32,611,074 |
) |
$ |
(183,524,137 |
) |
$ |
(176,144,999 |
) |
$ |
(132,617,160 |
) |
||||||
Loss per share, basic and diluted: | ||||||||||||||||||||||||
Net loss per share, basic and diluted |
$ |
(0.15 |
) |
$ |
(0.19 |
) |
$ |
(0.12 |
) |
$ |
(0.67 |
) |
$ |
(0.72 |
) |
$ |
(0.59 |
) |
||||||
Weighted average number of common shares outstanding, basic and diluted |
|
286,607,277 |
|
|
261,752,076 |
|
|
272,564,635 |
|
|
275,648,552 |
|
|
246,353,318 |
|
|
225,026,300 |
|
||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||
Year Ended December, 31, | ||||||||||||
2020 |
2019 |
2018 |
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
Net loss |
$ |
(183,524,137 |
) |
$ |
(176,144,999 |
) |
$ |
(132,617,160 |
) |
|||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation of fixed assets |
|
772,624 |
|
|
415,193 |
|
|
181,412 |
|
|||
Amortization of intangible assets |
|
269,546 |
|
|
197,593 |
|
|
112,474 |
|
|||
Write off of patent and trademark cost |
|
1,131,776 |
|
|
78,864 |
|
|
- |
|
|||
Write off of deferred financing fees |
|
275,379 |
|
|
- |
|
|
- |
|
|||
Non-cash operating lease expense |
|
1,405,443 |
|
|
1,062,318 |
|
|
- |
|
|||
Provision for doubtful accounts |
|
213,814 |
|
|
307,438 |
|
|
216,022 |
|
|||
Lease impairment |
|
136,832 |
|
. |
|
- |
|
|||||
Inventory charge |
|
7,204,818 |
|
|
- |
|
|
- |
|
|||
Loss on extinguishment of debt |
|
- |
|
|
10,057,632 |
|
|
- |
|
|||
Share-based compensation |
|
10,678,992 |
|
|
10,693,662 |
|
|
8,661,967 |
|
|||
Amortization of intellectual property license fee |
|
3,024,391 |
|
|
778,692 |
|
|
- |
|
|||
Amortization of deferred financing costs |
|
2,256,429 |
|
|
856,302 |
|
|
269,859 |
|
|||
Changes in operating assets and liabilities: | ||||||||||||
Accounts receivable |
|
(8,199,558 |
) |
|
(13,639,575 |
) |
|
(6,951,041 |
) |
|||
Inventory |
|
(3,337,189 |
) |
|
(8,593,046 |
) |
|
(1,782,312 |
) |
|||
Other assets |
|
3,429,443 |
|
|
(1,880,048 |
) |
|
(2,657,190 |
) |
|||
Accounts payable |
|
1,887,115 |
|
|
(3,562,629 |
) |
|
18,646,241 |
|
|||
Accrued expenses and other liabilities |
|
2,903,947 |
|
|
13,675,008 |
|
|
9,107,947 |
|
|||
Net cash used in operating activities |
|
(159,470,335 |
) |
|
(165,697,595 |
) |
|
(106,811,781 |
) |
|||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
Payment for intellectual property license |
|
- |
|
|
(20,000,000 |
) |
|
(20,000,000 |
) |
|||
Patent costs |
|
(1,390,834 |
) |
|
(1,441,989 |
) |
|
(1,105,407 |
) |
|||
Purchase of fixed assets |
|
(207,073 |
) |
|
(2,450,285 |
) |
|
(217,040 |
) |
|||
Payment of security deposit |
|
- |
|
|
(20,420 |
) |
|
(175,410 |
) |
|||
Net cash used in investing activities |
|
(1,597,907 |
) |
|
(23,912,694 |
) |
|
(21,497,857 |
) |
|||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
Proceeds from exercise of options and warrants |
|
271,678 |
|
|
108,656 |
|
|
1,666,208 |
|
|||
Proceeds from sale of common stock, net of costs |
|
31,702,635 |
|
|
77,031,258 |
|
|
89,907,797 |
|
|||
Proceeds from Financing Agreement |
|
50,000,000 |
|
|
200,000,000 |
|
|
- |
|
|||
Proceeds from Credit Agreement |
|
- |
|
|
- |
|
|
75,000,000 |
|
|||
Payment of deferred financing fees |
|
(1,250,000 |
) |
|
(6,652,270 |
) |
|
(3,786,918 |
) |
|||
Repayment of Credit Agreement |
|
- |
|
|
(81,660,719 |
) |
|
- |
|
|||
Net cash provided by financing activities |
|
80,724,313 |
|
|
188,826,925 |
|
|
162,787,087 |
|
|||
(Decrease) increase in cash |
|
(80,343,929 |
) |
|
(783,364 |
) |
|
34,477,449 |
|
|||
Cash, beginning of period |
|
160,829,713 |
|
|
161,613,077 |
|
|
127,135,628 |
|
|||
Cash, end of period |
$ |
80,485,784 |
|
$ |
160,829,713 |
|
$ |
161,613,077 |
|
|||
Supplemental disclosure of cash flow information | ||||||||||||
Interest paid |
$ |
25,849,236 |
|
$ |
17,787,903 |
|
$ |
1,890,166 |
|
|||
Non-cash investing activity | ||||||||||||
Warrant granted in relation to Financing Agreement |
$ |
7,668,161 |
|
$ |
- |
|
$ |
- |
|
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005416/en/
Investor Contact
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
Source: