- Quarterly total net product revenue of
- ANNOVERA® TRx of 8,014, an increase of 27% over Q1 2021 -
- Announced and completed vitaCare divestiture in five weeks -
- Conference call scheduled for
“Our revenue performance during the quarter was impacted by ANNOVERA manufacturing challenges as anticipated, but we believe these obstacles peaked in the first quarter of 2022 and expect incremental improvement as the year progresses. I’m also pleased to report that the
“With our increased focus and optimized sales organization, we believe that we will now be able to properly leverage all three of our assets and are confident these products can play a significant role in the marketplace,” concluded O’Dowd.
First Quarter 2022 Financial Results and Business Highlights
|
|
Three Months Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Product revenue: |
|
|
|
|
|
|
|
|
ANNOVERA |
|
$ |
8,510 |
|
|
$ |
8,750 |
|
IMVEXXY |
|
|
6,969 |
|
|
|
7,012 |
|
BIJUVA |
|
|
2,560 |
|
|
|
2,445 |
|
Prescription vitamin |
|
|
875 |
|
|
|
1,425 |
|
Product revenue, net |
|
|
18,914 |
|
|
|
19,632 |
|
License and service revenue |
|
|
419 |
|
|
|
234 |
|
Total revenue, net |
|
$ |
19,333 |
|
|
$ |
19,866 |
|
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
-
ANNOVERA net product revenue of
$8.5 million for the first quarter of 2022 decreased by approximately$0.3 million compared to$8.8 million for the first quarter of 2021. - Approximately 8,014 ANNOVERA prescriptions were dispensed to patients during the first quarter of 2022.
-
Over 3,601 healthcare providers (HCPs) prescribed ANNOVERA during the first quarter, of which 1,274 were new writers.
- Growth in prescribers of approximately 16% over first quarter of 2021.
IMVEXXY® (estradiol vaginal inserts)
-
IMVEXXY net product revenue of
$7.0 million for the first quarter of 2022 decreased by less than$0.1 million compared to$7.0 million for the first quarter of 2021. - Approximately 99,743 IMVEXXY prescriptions were dispensed to patients during the first quarter of 2022.
BIJUVA® (estradiol and progesterone) capsules
-
BIJUVA net product revenue of
$2.6 million for the first quarter of 2022 increased by approximately$0.2 million compared to$2.4 million for the first quarter of 2021. -
BIJUVA net product revenue for the first quarter of 2022 includes
$0.7 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
$4.9 million with product gross margin of 74% for the first quarter of 2022 compared to$4.7 million with product gross margin of 76% for the first quarter of 2021. The lower product gross margin for the first quarter of 2022 reflects the impact of$0.7 million of BIJUVA export sales, which were sold at cost.
Operating Expense, Net Loss and Related Information
-
Total operating expense of
$40.7 million for the first quarter of 2022 decreased by$3.8 million compared to$44.5 million for the first quarter of 2021. -
Net loss for the first quarter of 2022 was
$49.0 million , or$5.69 per basic and diluted share, compared to net loss for the first quarter of 2021 of$39.4 million , or$5.67 per basic and diluted share. Included in net loss for the first quarter of 2022 was a loss on extinguishment of debt of$8.4 million . Without this non-recurring non-operating expense item, net loss for the first quarter of 2022 would have been$40.6 million , or$4.72 per basic and diluted share.
Balance Sheet
-
As of
March 31, 2022 , the Company’s cash on hand totaled$30.4 million , compared with$65.1 million as ofDecember 31, 2021 . -
As of
March 31, 2022 , the remaining outstanding principal amount under the Company’s Financing Agreement was$225.0 million , which reflects a repayment of$5.0 million of principal during 2022 and an increase in debt related to a paid in kind ("PIK") debt financing fee of$30.0 million . OnApril 14, 2022 , the Company utilized$120.0 million of net proceeds from the divestiture of the vitaCarePrescription Services, Inc. business to paydown a portion of the debt, and$16.0 million of the PIK financing fee was waived.
Conference Call and Webcast Details
Date: |
|
||
Time: |
|
||
Telephone Access (US): |
866-665-9531 |
||
Telephone Access (International): |
724-987-6977 |
||
Access Code for All Callers: |
3179996 |
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
- Financial Statements to Follow -
Consolidated Balance Sheets | ||||||||
(Unaudited - in thousands, except per share data) | ||||||||
Assets: | ||||||||
Current assets: | ||||||||
Cash |
$ |
30,384 |
|
$ |
65,122 |
|
||
Accounts receivable, net of allowance for credit losses of |
|
35,413 |
|
|
36,176 |
|
||
Inventory |
|
8,967 |
|
|
7,622 |
|
||
Prepaid and other current assets |
|
9,660 |
|
|
10,548 |
|
||
Total current assets |
|
84,424 |
|
|
119,468 |
|
||
Fixed assets, net |
|
1,082 |
|
|
1,199 |
|
||
License rights and other intangible assets, net |
|
39,547 |
|
|
40,318 |
|
||
Right of use assets |
|
8,075 |
|
|
8,234 |
|
||
Other non-current assets |
|
253 |
|
|
253 |
|
||
Total assets |
$ |
133,381 |
|
$ |
169,472 |
|
||
Liabilities and stockholders' equity (deficit): | ||||||||
Current liabilities: | ||||||||
Current maturities of long-term debt |
$ |
202,857 |
|
$ |
188,269 |
|
||
Accounts payable |
|
20,753 |
|
|
20,318 |
|
||
Accrued expenses and other current liabilities |
|
41,225 |
|
|
44,304 |
|
||
Total current liabilities |
|
264,835 |
|
|
252,891 |
|
||
Operating lease liabilities |
|
7,897 |
|
|
8,063 |
|
||
Other non-current liabilities |
|
1,229 |
|
|
2,139 |
|
||
Total liabilities |
|
273,961 |
|
|
263,093 |
|
||
Commitments and contingencies | ||||||||
Stockholders' deficit: | ||||||||
Preferred stock, par value |
|
— |
|
|
— |
|
||
Common stock, par value |
|
9 |
|
|
9 |
|
||
Additional paid-in capital |
|
959,792 |
|
|
957,730 |
|
||
Accumulated deficit |
|
(1,100,381 |
) |
|
(1,051,360 |
) |
||
Total stockholders' deficit |
|
(140,580 |
) |
|
(93,621 |
) |
||
Total liabilities and stockholders' deficit |
$ |
133,381 |
|
$ |
169,472 |
|
Consolidated Statements of Operations | ||||||||
(Unaudited - in thousands, except per share data) | ||||||||
Three Months Ended |
||||||||
2022 |
|
2021 |
||||||
Revenue, net: | ||||||||
Product |
$ |
18,914 |
|
$ |
19,632 |
|
||
License and service |
|
419 |
|
|
234 |
|
||
Total revenue, net |
|
19,333 |
|
|
19,866 |
|
||
Cost of goods sold |
|
4,860 |
|
|
4,687 |
|
||
Total gross profit |
|
14,473 |
|
|
15,179 |
|
||
Operating expenses: | ||||||||
Selling and marketing |
|
18,895 |
|
|
24,024 |
|
||
General and administrative |
|
20,407 |
|
|
18,383 |
|
||
Research and development |
|
1,400 |
|
|
2,050 |
|
||
Total operating expenses |
|
40,702 |
|
|
44,457 |
|
||
Loss from operations |
|
(26,229 |
) |
|
(29,278 |
) |
||
Other expense: | ||||||||
Loss on extinguishment of debt |
|
(8,380 |
) |
|
— |
|
||
Interest expense and other financing costs |
|
(14,412 |
) |
|
(10,227 |
) |
||
Other income, net |
|
— |
|
|
122 |
|
||
Total other expense, net |
|
(22,792 |
) |
|
(10,105 |
) |
||
Loss before income taxes |
|
(49,021 |
) |
|
(39,383 |
) |
||
Provision for income taxes |
|
— |
|
|
— |
|
||
Net loss |
$ |
(49,021 |
) |
$ |
(39,383 |
) |
||
Loss per common share, basic and diluted |
$ |
(5.69 |
) |
$ |
(5.67 |
) |
||
Weighted average common shares, basic and diluted |
|
8,614 |
|
|
6,945 |
|
Consolidated Statements of Cash Flows | ||||||||
(Unaudited - in thousands) | ||||||||
Three Months Ended |
||||||||
2022 |
|
2021 |
||||||
Cash flows from operating activities: | ||||||||
Net loss |
$ |
(49,021 |
) |
$ |
(39,383 |
) |
||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization |
|
1,100 |
|
|
1,019 |
|
||
Charges to provision for doubtful accounts |
|
274 |
|
|
230 |
|
||
Inventory charge |
|
73 |
|
|
502 |
|
||
Debt financing fees |
|
9,048 |
|
|
1,272 |
|
||
Loss on extinguishment of debt |
|
8,380 |
|
|
— |
|
||
Share-based compensation |
|
2,062 |
|
|
2,957 |
|
||
Other |
|
(7 |
) |
|
216 |
|
||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable |
|
489 |
|
|
(1,567 |
) |
||
Inventory |
|
(1,418 |
) |
|
145 |
|
||
Prepaid and other current assets |
|
888 |
|
|
(817 |
) |
||
Accounts payable |
|
435 |
|
|
(10,758 |
) |
||
Accrued expenses and other current liabilities |
|
(1,829 |
) |
|
7,804 |
|
||
Total adjustments |
|
19,495 |
|
|
1,003 |
|
||
Net cash used in operating activities |
|
(29,526 |
) |
|
(38,380 |
) |
||
Cash flows from investing activities: | ||||||||
Payment of patent related costs |
|
(170 |
) |
|
(375 |
) |
||
Purchase of fixed assets |
|
(42 |
) |
|
(63 |
) |
||
Net cash used in investing activities |
|
(212 |
) |
|
(438 |
) |
||
Cash flows from financing activities: | ||||||||
Proceeds from sale of common stock, net of costs |
|
— |
|
|
150,899 |
|
||
Proceeds from exercise of options and warrants |
|
— |
|
|
50 |
|
||
Repayments of debt |
|
(5,000 |
) |
|
(50,000 |
) |
||
Payment of debt financing fees |
|
— |
|
|
(5,000 |
) |
||
Net cash (used in) provided by financing activities |
|
(5,000 |
) |
|
95,949 |
|
||
Net (decrease) increase in cash |
|
(34,738 |
) |
|
57,131 |
|
||
Cash, beginning of period |
|
65,122 |
|
|
80,486 |
|
||
Cash, end of period |
$ |
30,384 |
|
$ |
137,617 |
|
||
Supplemental disclosure of cash flow information: | ||||||||
Interest paid |
$ |
5,364 |
|
$ |
8,955 |
|
||
Supplemental disclosure of noncash financing activities: | ||||||||
Paid in kind ("PIK") debt financing fees with corresponding increase in debt |
$ |
30,000 |
|
$ |
— |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220516005177/en/
Interim Chief Financial Officer,
Chief Accounting Officer and
Vice President Finance
561-961-1900
212-452-2793
lwilson@insitecony.com
Source: