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
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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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