- Q3 total revenue of
- ANNOVERA TRx growth of 10% year-over-year -
- Reduced operating expenses by
“Our products continue to be adopted by healthcare providers and patients, and we continue to believe that they represent a significant opportunity. Our prescriber bases grew, and we added around 1,500 new prescribers for ANNOVERA and around 1,600 for IMVEXXY. Total quarterly prescriptions for both products remained relatively stable compared to the second quarter of 2022, and ANNOVERA’s total prescriptions grew 10% compared to the third quarter of 2021. While our third quarter 2022 net revenues declined
“During the quarter, we were able to move past the inventory issues we experienced in the first half of the year, and our wholesale network is now fully stocked. With these developments and the recent cash infusion from
Third Quarter 2022 Financial Results and Business Highlights
Three Months Ended |
|
Nine Months Ended |
||||||||||
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||
Product revenue: | ||||||||||||
ANNOVERA |
$ |
10,415 |
$ |
11,807 |
$ |
37,196 |
$ |
30,112 |
||||
IMVEXXY |
|
6,947 |
|
8,016 |
|
20,583 |
|
24,866 |
||||
BIJUVA |
|
2,663 |
|
3,298 |
|
7,877 |
|
7,899 |
||||
Prescription vitamin |
|
892 |
|
1,335 |
|
2,671 |
|
4,162 |
||||
Product revenue, net |
|
20,917 |
|
24,456 |
|
68,327 |
|
67,039 |
||||
License and service revenue |
|
— |
|
950 |
|
484 |
|
1,234 |
||||
Total revenue, net |
$ |
20,917 |
$ |
25,406 |
$ |
68,811 |
$ |
68,273 |
||||
ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system)
-
ANNOVERA net product revenue of
$10.4 million for the third quarter of 2022 decreased by$1.4 million compared to$11.8 million for the third quarter of 2021. - Approximately 9,200 ANNOVERA prescriptions were dispensed to patients during the third quarter of 2022.
- Over 15,000 healthcare providers (HCPs) prescribed ANNOVERA since launch through the third quarter of 2022, of which more than 1,500 were new writers.
IMVEXXY® (estradiol vaginal inserts)
-
IMVEXXY net product revenue of
$6.9 million for the third quarter of 2022 decreased by$1.1 million compared to$8.0 million for the third quarter of 2021. - Approximately 91,300 IMVEXXY prescriptions were dispensed to patients during the third quarter of 2022.
BIJUVA® (estradiol and progesterone) capsules
-
BIJUVA net product revenue of
$2.7 million for the third quarter of 2022 decreased by approximately$0.6 million compared to$3.3 million for the third quarter of 2021. -
BIJUVA net product revenue for the third quarter of 2022 includes
$0.4 million of export sales through our international licensing and supply agreement withTheramex HQ UK Limited .
Cost of Goods Sold and Gross Margin
-
Cost of goods was
$3.8 million with product gross margin of 82% for the third quarter of 2022 compared to$5.3 million with product gross margin of 78% for the third quarter of 2021. The increase in product gross margins was mainly due to changes in product sales mix.
Operating Expense, Net Loss and Related Information
-
Total operating expense of
$37.9 million for the third quarter of 2022 decreased by approximately$22.2 million compared to$60.0 million for the third quarter of 2021. -
Net loss for the third quarter of 2022 was
$29.0 million , or$3.13 per basic and diluted share, compared to net loss for the third quarter of 2021 of$47.4 million , or$5.62 per basic and diluted share.
Balance Sheet
-
As of
September 30, 2022 , the Company’s cash on hand totaled$27.1 million , compared with$65.1 million as ofDecember 31, 2021 . Subsequent to quarter end, the Company closed a$7 million private investment in the Company’s Series A Preferred Stock fromRubric Capital Management LP . The Company also had$11.3 million in restricted cash related to customary holdbacks as part of the vitaCare Prescription Services divestiture. -
As of
September 30, 2022 , the Company’s aggregate balance of net debt, lender warrants derivative liability, make-whole payment derivative liability and mandatory redeemable preferred stock was$117.1 million .
In light of the Company’s ongoing strategic alternatives process, the Company will not be hosting a conference call.
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
- Financial Statements to Follow -
Consolidated Balance Sheets | ||||||||
(Unaudited - in thousands, except per share data) | ||||||||
Assets: | ||||||||
Current assets: | ||||||||
Cash |
$ |
27,080 |
|
$ |
65,122 |
|
||
Restricted cash |
|
11,250 |
|
|
— |
|
||
Accounts receivable, net of allowance for credit losses of |
|
32,157 |
|
|
36,176 |
|
||
Inventory |
|
6,701 |
|
|
7,622 |
|
||
Prepaid and other current assets |
|
10,290 |
|
|
10,548 |
|
||
Total current assets |
|
87,478 |
|
|
119,468 |
|
||
Fixed assets, net |
|
551 |
|
|
1,199 |
|
||
License rights and other intangible assets, net |
|
37,876 |
|
|
40,318 |
|
||
Right of use assets |
|
7,749 |
|
|
8,234 |
|
||
Other non-current assets |
|
253 |
|
|
253 |
|
||
Total assets |
$ |
133,907 |
|
$ |
169,472 |
|
||
Liabilities and stockholders' deficit: | ||||||||
Current liabilities: | ||||||||
Debt, net |
$ |
93,602 |
|
$ |
188,269 |
|
||
Lender Warrants derivative liability |
|
2,058 |
|
|
— |
|
||
Make-whole payment derivative liability |
|
1,751 |
|
|
— |
|
||
Mandatory Redeemable Preferred Stock |
|
19,709 |
|
|
— |
|
||
Accounts payable |
|
13,383 |
|
|
20,318 |
|
||
Accrued expenses and other current liabilities |
|
43,568 |
|
|
44,304 |
|
||
Total current liabilities |
|
174,071 |
|
|
252,891 |
|
||
Operating lease liabilities |
|
7,553 |
|
|
8,063 |
|
||
Other non-current liabilities |
|
554 |
|
|
2,139 |
|
||
Total liabilities |
|
182,178 |
|
|
263,093 |
|
||
Commitments and contingencies | ||||||||
Stockholders' deficit: | ||||||||
Preferred stock, par value |
||||||||
and included in liabilities due to their redemption provisions |
|
— |
|
|
— |
|
||
Common stock, par value |
|
9 |
|
|
9 |
|
||
Additional paid-in capital |
|
968,785 |
|
|
957,730 |
|
||
Accumulated deficit |
|
(1,017,065 |
) |
|
(1,051,360 |
) |
||
Total stockholders' deficit |
|
(48,271 |
) |
|
(93,621 |
) |
||
Total liabilities and stockholders' deficit |
$ |
133,907 |
|
$ |
169,472 |
|
||
Consolidated Statements of Operations | ||||||||||||||||
(Unaudited - in thousands, except per share data) | ||||||||||||||||
Three Months Ended |
|
Nine Months Ended |
||||||||||||||
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||||
Revenue, net: | ||||||||||||||||
Product |
$ |
20,917 |
|
$ |
24,456 |
|
$ |
68,327 |
|
$ |
67,039 |
|
||||
License and service |
|
— |
|
|
950 |
|
|
484 |
|
|
1,234 |
|
||||
Total revenue, net |
|
20,917 |
|
|
25,406 |
|
|
68,811 |
|
|
68,273 |
|
||||
Cost of goods sold |
|
3,788 |
|
|
5,282 |
|
|
13,388 |
|
|
14,101 |
|
||||
Total gross profit |
|
17,129 |
|
|
20,124 |
|
|
55,423 |
|
|
54,172 |
|
||||
Operating expenses: | ||||||||||||||||
Selling and marketing |
|
19,129 |
|
|
30,005 |
|
|
61,703 |
|
|
86,193 |
|
||||
General and administrative |
|
17,635 |
|
|
28,435 |
|
|
55,445 |
|
|
66,691 |
|
||||
Research and development |
|
1,112 |
|
|
1,605 |
|
|
4,092 |
|
|
5,666 |
|
||||
Total operating expenses |
|
37,876 |
|
|
60,045 |
|
|
121,240 |
|
|
158,550 |
|
||||
Loss from operations |
|
(20,747 |
) |
|
(39,921 |
) |
|
(65,817 |
) |
|
(104,378 |
) |
||||
Other (expense) income: | ||||||||||||||||
Gain on sale of business |
|
— |
|
|
— |
|
|
143,384 |
|
|
— |
|
||||
Expense for accretion of Mandatory Redeemable Preferred Stock |
|
(3,457 |
) |
|
— |
|
|
(3,457 |
) |
|
— |
|
||||
Fair value loss on Lender Warrants derivative liability |
|
(76 |
) |
|
— |
|
|
(76 |
) |
|
— |
|
||||
Loss on extinguishment of debt |
|
— |
|
|
— |
|
|
(8,380 |
) |
|
— |
|
||||
Interest expense and other financing costs |
|
(4,833 |
) |
|
(7,518 |
) |
|
(30,941 |
) |
|
(25,341 |
) |
||||
Other (expense) income, net |
|
(112 |
) |
|
19 |
|
|
(128 |
) |
|
264 |
|
||||
Total other (expense) income, net |
|
(8,478 |
) |
|
(7,499 |
) |
|
100,402 |
|
|
(25,077 |
) |
||||
(Loss) income before income taxes |
|
(29,225 |
) |
|
(47,420 |
) |
|
34,585 |
|
|
(129,455 |
) |
||||
(Benefit) provision for income taxes |
|
(260 |
) |
|
— |
|
|
290 |
|
|
— |
|
||||
Net (loss) income |
$ |
(28,965 |
) |
$ |
(47,420 |
) |
$ |
34,295 |
|
$ |
(129,455 |
) |
||||
(Loss) earnings per common share, basic |
$ |
(3.13 |
) |
$ |
(5.62 |
) |
$ |
3.86 |
|
$ |
(16.68 |
) |
||||
Weighted average common shares, basic |
|
9,261 |
|
|
8,444 |
|
|
8,877 |
|
|
7,762 |
|
||||
(Loss) earnings per common share, diluted |
$ |
(3.13 |
) |
$ |
(5.62 |
) |
$ |
3.73 |
|
$ |
(16.68 |
) |
||||
Weighted average common shares, diluted |
|
9,261 |
|
|
8,444 |
|
|
9,205 |
|
|
7,762 |
|
||||
Consolidated Statements of Cash Flows | ||||||||
(Unaudited - in thousands) | ||||||||
Nine Months Ended |
||||||||
2022 |
|
2021 |
||||||
Cash flows from operating activities: | ||||||||
Net income (loss) |
$ |
34,295 |
|
$ |
(129,455 |
) |
||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||||
Depreciation and amortization |
|
3,181 |
|
|
3,091 |
|
||
Charges to provision for doubtful accounts |
|
542 |
|
|
540 |
|
||
Inventory charge |
|
73 |
|
|
1,082 |
|
||
Debt financing fees |
|
20,053 |
|
|
4,158 |
|
||
Share-based compensation |
|
8,587 |
|
|
12,779 |
|
||
Gain on sale of business |
|
(143,384 |
) |
|
— |
|
||
Expense for accretion of Mandatory Redeemable Preferred Stock |
|
3,457 |
|
|
— |
|
||
Loss on extinguishment of debt |
|
8,380 |
|
|
— |
|
||
Other |
|
50 |
|
|
726 |
|
||
Changes in operating assets and liabilities: |
|
|
|
|
||||
Accounts receivable |
|
3,044 |
|
|
(5,560 |
) |
||
Inventory |
|
848 |
|
|
(451 |
) |
||
Prepaid and other current assets |
|
180 |
|
|
(2,831 |
) |
||
Accounts payable |
|
(6,186 |
) |
|
(1,476 |
) |
||
Accrued expenses and other current liabilities |
|
3,705 |
|
|
13,504 |
|
||
Other non-current liabilities |
|
(675 |
) |
|
758 |
|
||
Total adjustments |
|
(98,145 |
) |
|
26,320 |
|
||
Net cash used in operating activities |
|
(63,850 |
) |
|
(103,135 |
) |
||
Cash flows from investing activities: | ||||||||
Proceeds from sale of business, net of transaction costs |
|
142,634 |
|
|
— |
|
||
Payment of patent related costs |
|
(297 |
) |
|
(675 |
) |
||
Purchase of fixed assets |
|
(21 |
) |
|
(34 |
) |
||
Net cash provided by (used in) investing activities |
|
142,316 |
|
|
(709 |
) |
||
Cash flows from financing activities: | ||||||||
Proceeds from sale of Mandatory Redeemable Preferred Stock, net of costs |
|
16,252 |
|
|
— |
|
||
Proceeds from make-whole derivative |
|
1,751 |
|
|
— |
|
||
Proceeds from sale of common stock, net of costs |
|
2,454 |
|
|
182,881 |
|
||
Proceeds from exercise of options and warrants |
|
— |
|
|
302 |
|
||
Proceeds from sale of common stock related to employee stock purchase plan |
|
14 |
|
|
134 |
|
||
Repayments of debt |
|
(125,000 |
) |
|
(50,000 |
) |
||
Payment of debt financing fees |
|
(729 |
) |
|
(5,118 |
) |
||
Net cash (used in) provided by financing activities |
|
(105,258 |
) |
|
128,199 |
|
||
Net (decrease) increase in cash and restricted cash |
|
(26,792 |
) |
|
24,355 |
|
||
Cash and restricted cash, beginning of period |
|
65,122 |
|
|
80,486 |
|
||
Cash and restricted cash, end of period |
$ |
38,330 |
|
$ |
104,841 |
|
||
Supplemental disclosure of cash flow information: | ||||||||
Interest paid |
$ |
8,371 |
|
$ |
19,675 |
|
||
Supplemental disclosure of noncash financing activities: | ||||||||
Paid in kind ("PIK") interest with corresponding increase in debt |
$ |
2,452 |
|
$ |
— |
|
||
PIK debt financing fees with corresponding increase in debt |
$ |
16,980 |
|
$ |
— |
|
||
Issue of warrants to lenders related to debt financing fees |
$ |
1,983 |
|
$ |
— |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20221114005733/en/
Interim Chief Financial Officer,
Chief Accounting Officer and
Vice President Finance
561-961-1900
212-452-2793
lwilson@insitecony.com
Source: