Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress
Core royalty platform on track; received GSK royalties of
Achieved net product revenues of
Strong pipeline progress in 2023: Approval and launch of first pathogen targeted antibacterial XACDURO® for treatment of HABP/VABP caused by Acinetobacter infections; positive topline Phase 3 data for oral drug zoliflodacin for treatment of uncomplicated gonorrhea
Repurchased 1.1 million our common stock for
Financial Highlights
-
Royalty revenue: Fourth quarter 2023 gross royalty revenue from
Glaxo Group Limited (“GSK”) was$69.6 million and full year was$252.7 million , compared to$54.7 million for the fourth quarter of 2022 and$253.4 million for the full year 2022.
-
Net Product Sales: Fourth quarter 2023 net product sales and license revenue were
$19.7 million , which included$13.1 million from GIAPREZA®,$5.2 million from XERAVA®, and$1.4 million from XACDURO®, compared to$14.6 million for the fourth quarter of 2022. Full year 2023 net product sales and license revenue was$71.6 million , which included$41.3 million from GIAPREZA®,$17.3 million from XERAVA®,$2.0 million from XACDURO®, and$11.0 million in milestone payments from our partners.
-
Equity and long-term investments: Fourth quarter and full year 2023 change in fair values of equity and long-term investments of
$25.5 million and$88.5 million , respectively, was primarily attributable to Armata Pharmaceuticals (“Armata”) share price appreciation.
-
Net income: Fourth quarter 2023 net income was
$61.5 million , or$0.97 basic per share, compared to a net loss of$68.3 million , or$(0.98) basic per share, for the fourth quarter 2022, driven primarily by higher revenue and positive impact of change in fair values of equity. Full year 2023 net income was$179.7 million , or$2.75 basic per share, compared to net income of$213.9 million , or$3.07 basic per share, for the full year 2022.
-
Share repurchase: During the fourth quarter 2023,
Innoviva repurchased 1,121,835 shares of its outstanding common stock for$15.4 million . During the year 2023,Innoviva repurchased 6,173,565 shares of its outstanding common stock for$76.5 million . Approximately$15 million of the authorized program remains outstanding as of year-end.
-
Cash and cash equivalents: Totaled
$193.5 million . Royalty and net product sales receivables totaled$84.1 million as ofDecember 31, 2023 .
Key 2023 R&D Highlights
-
Zoliflodacin: potential first-in-class oral antibiotic to treat uncomplicated gonorrhea
-
In
November 2023 , in collaboration withThe Global Antibiotic Research & Development Partnership (GARDP),Innoviva announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in a global pivotal phase 3 clinical trial for the treatment of uncomplicated gonorrhea. The Company expects a New Drug Application to be submitted to theU.S. FDA in the next twelve months.
-
In
-
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for HABP/VABP caused by Acinetobacter
-
In
May 2023 , theU.S. Food and Drug Administration (FDA) approved XACDURO® for use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. - Earlier in May, The Lancet Infectious Diseases published detailed results from the pivotal Phase 3 ATTACK trial of sulbactam-durlobactam.
-
In
Update on Strategic Healthcare Assets
-
Our portfolio of strategic assets under the Company’s various subsidiaries was valued at
$561.0 million as ofDecember 31, 2023 . In fourth quarter 2023,Innoviva invested an additional$5.0 million in one of our assets, Gate Neurosciences, to support its strategy of developing next generation targeted CNS therapies.
About
ANORO®, RELVAR®, BREO® and TRELEGY® are trademarks of the GSK group of companies.
Forward Looking Statements
This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events.
Condensed Consolidated Statements of Income | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|||||
Revenue: | ||||||||||||||||
Royalty revenue, net (1) |
$ |
66,165 |
|
$ |
51,216 |
|
$ |
238,846 |
|
$ |
311,645 |
|
||||
Net product sales |
|
19,675 |
|
|
14,587 |
|
|
60,617 |
|
|
19,694 |
|
||||
License Revenue |
|
- |
|
|
- |
|
|
11,000 |
|
|
- |
|
||||
Total revenue |
|
85,840 |
|
|
65,803 |
|
|
310,463 |
|
|
331,339 |
|
||||
Expenses: | ||||||||||||||||
Cost of products sold (inclusive of amortization of inventory fair value adjustments) |
|
13,130 |
|
|
10,113 |
|
|
41,040 |
|
|
13,793 |
|
||||
Cost of license revenue |
|
- |
|
|
- |
|
|
1,600 |
|
|
- |
|
||||
Selling, general and administrative |
|
26,319 |
|
|
17,454 |
|
|
98,232 |
|
|
63,538 |
|
||||
Research and development |
|
2,356 |
|
|
9,985 |
|
|
33,922 |
|
|
41,432 |
|
||||
Amortization of acquired intangible assets |
|
6,510 |
|
|
4,070 |
|
|
21,784 |
|
|
5,581 |
|
||||
Gain on TRC sale |
|
- |
|
|
- |
|
|
- |
|
|
(266,696 |
) |
||||
Loss on debt extinguishment |
|
- |
|
|
- |
|
|
- |
|
|
20,662 |
|
||||
Changes in fair values of equity method investments, net |
|
(9,506 |
) |
|
117,274 |
|
|
(77,392 |
) |
|
161,749 |
|
||||
Changes in fair values of equity and long-term investments, net |
|
(16,016 |
) |
|
(31,868 |
) |
|
(11,129 |
) |
|
(8,462 |
) |
||||
Interest and dividend income |
|
(4,786 |
) |
|
(3,188 |
) |
|
(15,818 |
) |
|
(6,369 |
) |
||||
Interest expense |
|
5,952 |
|
|
4,028 |
|
|
19,157 |
|
|
15,789 |
|
||||
Other expense (income), net |
|
680 |
|
|
2,623 |
|
|
4,969 |
|
|
3,373 |
|
||||
Total expenses |
|
24,639 |
|
|
130,491 |
|
|
116,365 |
|
|
44,390 |
|
||||
Income before income taxes |
|
61,201 |
|
|
(64,688 |
) |
|
194,098 |
|
|
286,949 |
|
||||
Income tax expense |
|
(330 |
) |
|
3,626 |
|
|
14,376 |
|
|
66,687 |
|
||||
Net income |
|
61,531 |
|
|
(68,314 |
) |
|
179,722 |
|
|
220,262 |
|
||||
Net income attributable to noncontrolling interest |
|
- |
|
|
- |
|
|
- |
|
|
6,341 |
|
||||
Net income attributable to |
$ |
61,531 |
|
$ |
(68,314 |
) |
$ |
179,722 |
|
$ |
213,921 |
|
||||
Basic net income per share attributable to |
$ |
0.97 |
|
$ |
(0.98 |
) |
$ |
2.75 |
|
$ |
3.07 |
|
||||
Diluted net income per share attributable to |
$ |
0.76 |
|
$ |
(0.98 |
) |
$ |
2.20 |
|
$ |
2.37 |
|
||||
Shares used to compute basic net income per share |
|
63,710 |
|
|
69,656 |
|
|
65,435 |
|
|
69,644 |
|
||||
Shares used to compute diluted net income per share |
|
84,995 |
|
|
69,656 |
|
|
86,876 |
|
|
95,248 |
|
||||
(1) Total net revenue is comprised of the following (in thousands): | |||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||||
(unaudited) | (unaudited) | ||||||||||||||||
Royalties |
$ |
69,620 |
|
$ |
54,671 |
|
$ |
252,669 |
|
$ |
325,468 |
|
|||||
Amortization of capitalized fees |
|
(3,455 |
) |
|
(3,455 |
) |
|
(13,823 |
) |
|
(13,823 |
) |
|||||
Royalty revenue, net |
$ |
66,165 |
|
$ |
51,216 |
|
$ |
238,846 |
|
$ |
311,645 |
|
|||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
|
2023 |
|
2022 |
||||
Assets | |||||||
Cash and cash equivalents |
$ |
193,513 |
$ |
291,049 |
|||
Royalty and product sale receivables |
|
84,075 |
|
64,073 |
|||
Inventory, net |
|
40,737 |
|
55,897 |
|||
Prepaid expense and other current assets |
|
25,894 |
|
32,492 |
|||
Property and equipment, net |
|
483 |
|
170 |
|||
Equity and long-term investments |
|
560,978 |
|
403,013 |
|||
Capitalized fees |
|
83,784 |
|
97,607 |
|||
Right-of-use assets |
|
2,536 |
|
3,265 |
|||
|
17,905 |
|
26,713 |
||||
Intangible assets |
|
230,335 |
|
252,919 |
|||
Other assets |
|
3,267 |
|
4,299 |
|||
Total assets |
$ |
1,243,507 |
$ |
1,231,497 |
|||
Liabilities and stockholders’ equity | |||||||
Other current liabilities |
$ |
33,435 |
$ |
32,322 |
|||
Accrued interest payable |
|
3,422 |
|
4,359 |
|||
Deferred revenues |
|
1,277 |
|
2,094 |
|||
Convertible subordinated notes, due 2023, net |
|
- |
|
96,193 |
|||
Convertible senior notes, due 2025, net |
|
191,295 |
|
190,583 |
|||
Convertible senior notes, due 2028, net |
|
254,939 |
|
253,597 |
|||
Other long term liabilities |
|
71,870 |
|
70,918 |
|||
Deferred tax liabilities |
|
563 |
|
5,771 |
|||
Income tax payable - long term |
|
11,751 |
|
9,872 |
|||
|
674,955 |
|
565,788 |
||||
Total liabilities and stockholders’ equity |
$ |
1,243,507 |
$ |
1,231,497 |
Cash Flows Summary | ||||||||
(in thousands) | ||||||||
(unaudited) | ||||||||
Year Ended |
||||||||
|
2023 |
|
|
2022 |
|
|||
Net cash provided by operating activities |
$ |
141,064 |
|
$ |
201,726 |
|
||
Net cash used in investing activities |
|
(66,761 |
) |
|
(56,634 |
) |
||
Net cash used in financing activities |
|
(171,839 |
) |
|
(55,568 |
) |
||
Net change |
$ |
(97,536 |
) |
$ |
89,524 |
|
||
Cash and cash equivalents at beginning of period |
|
291,049 |
|
|
201,525 |
|
||
Cash and cash equivalents at end of period |
$ |
193,513 |
|
$ |
291,049 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229441244/en/
Corporate Communications
(908) 421-5971
david.patti@inva.com
Investors and Media:
(212) 600-1902
innoviva@argotpartners.com
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