Innoviva Reports Second Quarter 2024 Financial Results; Highlights Recent Company Progress
Core royalty platform continued strong performance, receiving GSK royalties of
Important treatment guidelines and guidance updates recognized our key products: XACDURO
®
by 2024
XACDURO® approved in
“Our robust second quarter continues to demonstrate the successful transformation of
Financial Highlights
-
Royalty revenue: Second quarter 2024 gross royalty revenue from
Glaxo Group Limited (“GSK”) was$67.2 million , compared to$65.7 million for the second quarter 2023. -
Net Product Sales: Second quarter 2024 net product sales were
$21.7 million , which included$13.1 million from GIAPREZA®,$6.2 million from XERAVA®, and$2.4 million from XACDURO®, a 38% increase compared to$15.7 million for the second quarter 2023. -
License Revenue: Second quarter 2024 license revenue of
$14.5 million included an$8 million milestone payment from our partner for the regulatory approval of XACDURO® inChina and$6.5 million in non-recurring cost-sharing reimbursements from our partner for product development. -
Equity and long-term investments: Second quarter 2024 net unfavorable change in fair values of equity and long-term investments of
$90.7 million was primarily attributable to lower share price of Armata Pharmaceuticals (“Armata”), despite continued operational progress. -
Net income: The change in fair values of our investments negatively impacted second quarter 2024 earnings, resulting in a net loss of
$34.7 million , or ($0.55 ) basic per share, compared to a net income of$1.3 million , or$0.02 basic per share, for the second quarter of 2023. -
Share repurchases: During the second quarter 2024,
Innoviva completed its$100 million share repurchase program by repurchasing 0.4 million shares, for a total amount of approximately$5.3 million . -
Cash and cash equivalents: Totaled
$217.0 million . Royalty and net product sales receivables totaled$94.0 million as ofJune 30, 2024 .
Key Business and R&D Highlights
-
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii calcoaceticus complex.
-
In
May 2024 , XACDURO® was approved inChina by theNational Medical Products Administration (NMPA) for use in Chinese patients 18 years of age and older. -
In
July 2024 , XACDURO® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance. -
The
World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics1.
-
In
-
XERAVA® (eravacycline), for injection is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms in patients 18 years or older.
-
In
July 2024 , XERAVA® was named as a recommended agent for empiric therapy in the updated 2024 SIS treatment guidelines for the management of complicated intra-abdominal infections. SIS also recommended XERAVA® be reserved for high-risk patients.
-
In
-
Zoliflodacin: a potential first-in-class, single dose, oral antibiotic in development for the treatment of patients with uncomplicated gonorrhea is currently being developed in partnership with
The Global Antibiotic Research & Development Partnership (GARDP).-
Zoliflodacin has successfully completed Phase 3 clinical trials and the results were reported at ESCMID Global 2024. The Company expects to submit an NDA to the
U.S. FDA in early 2025.
-
Zoliflodacin has successfully completed Phase 3 clinical trials and the results were reported at ESCMID Global 2024. The Company expects to submit an NDA to the
About
ANORO®, RELVAR® and BREO® 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.
References
|
||||||||||||||||
Condensed Consolidated Statements of Income and Comprehensive Income | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
|
|
|||||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenue: | ||||||||||||||||
Royalty revenue, net (1) |
$ |
63,742 |
|
$ |
62,265 |
|
$ |
122,157 |
|
$ |
119,123 |
|
||||
Net product sales |
|
21,651 |
|
|
15,727 |
|
|
40,735 |
|
|
27,241 |
|
||||
License revenue |
|
14,505 |
|
|
3,000 |
|
|
14,505 |
|
|
11,000 |
|
||||
Total revenue |
|
99,898 |
|
|
80,992 |
|
|
177,397 |
|
|
157,364 |
|
||||
Expenses: | ||||||||||||||||
Cost of products sold (inclusive of amortization of inventory fair value adjustments) |
|
8,472 |
|
|
8,979 |
|
|
19,443 |
|
|
17,728 |
|
||||
Cost of license revenue |
|
- |
|
|
- |
|
|
- |
|
|
1,600 |
|
||||
Selling, general and administrative |
|
27,740 |
|
|
23,542 |
|
|
58,145 |
|
|
43,277 |
|
||||
Research and development |
|
2,560 |
|
|
14,989 |
|
|
6,438 |
|
|
27,577 |
|
||||
Amortization of acquired intangible assets |
|
6,440 |
|
|
4,958 |
|
|
12,880 |
|
|
8,763 |
|
||||
Changes in fair values of equity method investments, net |
|
60,108 |
|
|
19,911 |
|
|
24,766 |
|
|
4,094 |
|
||||
Changes in fair values of equity and long-term investments, net |
|
30,556 |
|
|
83 |
|
|
43,891 |
|
|
2,247 |
|
||||
Interest and dividend income |
|
(3,474 |
) |
|
(3,553 |
) |
|
(7,873 |
) |
|
(6,918 |
) |
||||
Interest expense |
|
5,802 |
|
|
4,382 |
|
|
11,653 |
|
|
8,809 |
|
||||
Other expense, net |
|
973 |
|
|
1,896 |
|
|
2,209 |
|
|
3,242 |
|
||||
Total expenses, net |
|
139,177 |
|
|
75,187 |
|
|
171,552 |
|
|
110,419 |
|
||||
Income (loss) before income taxes |
|
(39,279 |
) |
|
5,805 |
|
|
5,845 |
|
|
46,945 |
|
||||
Income tax expense (benefit), net |
|
(4,594 |
) |
|
4,525 |
|
|
3,998 |
|
|
10,800 |
|
||||
Net income (loss) and comprehensive income (loss) |
$ |
(34,685 |
) |
$ |
1,280 |
|
$ |
1,847 |
|
$ |
36,145 |
|
||||
Net income (loss) per share | ||||||||||||||||
Basic |
$ |
(0.55 |
) |
$ |
0.02 |
|
$ |
0.03 |
|
$ |
0.54 |
|
||||
Diluted |
$ |
(0.55 |
) |
$ |
0.02 |
|
$ |
0.03 |
|
$ |
0.46 |
|
||||
Shares used to compute net income (loss) per share | ||||||||||||||||
Basic |
|
62,526 |
|
|
65,341 |
|
|
62,856 |
|
|
66,557 |
|
||||
Diluted |
|
62,526 |
|
|
65,489 |
|
|
63,064 |
|
|
88,175 |
|
(1) Total net revenue is comprised of the following (in thousands): | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
|
|
|||||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
(unaudited) | (unaudited) | |||||||||||||||
Royalties |
$ |
67,198 |
|
$ |
65,721 |
|
$ |
129,069 |
|
$ |
126,035 |
|
||||
Amortization of capitalized fees |
|
(3,456 |
) |
|
(3,456 |
) |
|
(6,912 |
) |
|
(6,912 |
) |
||||
Royalty revenue, net |
$ |
63,742 |
|
$ |
62,265 |
|
$ |
122,157 |
|
$ |
119,123 |
|
||||
|
|||||
Condensed Consolidated Balance Sheets | |||||
(in thousands) | |||||
(unaudited) | |||||
|
|
||||
2024 |
2023 |
||||
Assets | |||||
Cash and cash equivalents |
$ |
217,003 |
$ |
193,513 |
|
Royalty and product sale receivables |
|
93,980 |
|
84,075 |
|
Inventory |
|
36,664 |
|
40,737 |
|
Prepaid expense and other current assets |
|
10,630 |
|
25,894 |
|
Property and equipment, net |
|
427 |
|
483 |
|
Equity and long-term investments |
|
536,435 |
|
560,978 |
|
Capitalized fees paid, net |
|
76,872 |
|
83,784 |
|
Right-of-use assets |
|
3,118 |
|
2,536 |
|
|
|
17,905 |
|
17,905 |
|
Intangible assets |
|
217,455 |
|
230,335 |
|
Deferred tax asset, net |
|
11,446 |
|
- |
|
Other assets |
|
2,982 |
|
3,267 |
|
Total assets |
$ |
1,224,917 |
$ |
1,243,507 |
|
Liabilities and stockholders’ equity | |||||
Other current liabilities |
$ |
23,929 |
$ |
33,435 |
|
Accrued interest payable |
|
3,422 |
|
3,422 |
|
Deferred revenue |
|
855 |
|
1,277 |
|
Convertible senior notes, due 2025, net |
|
191,659 |
|
191,295 |
|
Convertible senior notes, due 2028, net |
|
255,623 |
|
254,939 |
|
Other long-term liabilities |
|
72,065 |
|
71,870 |
|
Deferred tax liabilities, net |
|
- |
|
563 |
|
Income tax payable, long-term |
|
11,849 |
|
11,751 |
|
|
|
665,515 |
|
674,955 |
|
Total liabilities and stockholders’ equity |
$ |
1,224,917 |
$ |
1,243,507 |
|
|||||||
Cash Flows Summary | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
Six Months Ended | |||||||
|
|||||||
|
|
2024 |
|
|
|
2023 |
|
Net cash provided by operating activities |
$ |
80,765 |
|
$ |
63,866 |
|
|
Net cash used in investing activities |
|
(43,038 |
) |
|
(35,722 |
) |
|
Net cash used in financing activities |
|
(14,237 |
) |
|
(146,168 |
) |
|
Net change |
$ |
23,490 |
|
$ |
(118,024 |
) |
|
Cash and cash equivalents at beginning of period |
|
193,513 |
|
|
291,049 |
|
|
Cash and cash equivalents at end of period |
$ |
217,003 |
|
$ |
173,025 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240731216589/en/
Corporate Communications
(908) 421-5971
david.patti@inva.com
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