Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress
Core royalty platform on track; receiving GSK royalties of
Achieved net product revenues of
Strong pipeline progress: positive Phase 3 zoliflodacin clinical trial results in uncomplicated gonorrhea highlighted at ESCMID Global 2024; on track to submit NDA in early 2025
“Our first quarter financial results continue to demonstrate the successful transformation for
Financial Highlights
-
Royalty revenue: First quarter 2024 gross royalty revenue from
Glaxo Group Limited (“GSK”) was$61.9 million , compared to$60.3 million for the first quarter of 2023. -
Net Product Sales: First quarter 2024 net product sales and license revenue were
$19.1 million , which included$12.1 million from GIAPREZA®,$4.8 million from XERAVA®, and$2.2 million from XACDURO®, a 66% increase compared to$11.5 million for the first quarter of 2023. -
Equity and long-term investments: First quarter 2024 net change in fair values of equity and long-term investments of
$22.0 million was primarily attributable to Armata Pharmaceuticals (“Armata”) share price appreciation. -
Net income: First quarter 2024 net income was
$36.5 million , or$0.58 basic per share, compared to a net income of$34.9 million , or$0.51 basic per share, for the first quarter of 2023. -
Share repurchases: During the first quarter 2024,
Innoviva repurchased 0.6 million shares of its outstanding common stock for$9.7 million . Subsequent toMarch 31, 2024 , and throughApril 25, 2024 , we completed the program by repurchasing 0.4 million shares for a total amount of approximately$5.3 million . -
Cash and cash equivalents: Totaled
$178.4 million . Royalty and net product sales receivables totaled$76.0 million as ofMarch 31, 2024 .
Key Business and R&D Highlights
-
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for patients with HABP/VABP caused by Acinetobacter
-
Following the launch in
September 2023 , commercial efforts continue to deliver strong performance with growing number of health systems integrating XACDURO® into their protocols.
-
Following the launch in
-
Zoliflodacin: a potential first-in-class, single dose, oral antibiotic in development for the treatment of patients with uncomplicated gonorrhea
-
Positive Phase 3 zoliflodacin clinical trial results highlighted in an oral presentation given by the Company’s non-profit partner,
The Global Antibiotic Research & Development Partnership (GARDP), at theEuropean Society of Clinical Microbiology andInfectious Disease Global Congress (ESCMID Global 2024). - The data showed that in the micro-intent-to-treat population (n=744), zoliflodacin achieved a microbiological cure rate of 90.9%, a 5.3% difference compared to ceftriaxone and azithromycin, the current global standard of care, which achieved a 96.2% cure rate (95% CI: 1.4%, 8.7%). Microbiological cure rates at extragenital sites were comparable between treatment arms (secondary endpoints). Zoliflodacin was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs 46.4%). No deaths or other serious adverse events were reported.
-
The Company expects a New Drug Application to be submitted to the
U.S. FDA in early 2025.
-
Positive Phase 3 zoliflodacin clinical trial results highlighted in an oral presentation given by the Company’s non-profit partner,
Strategic Healthcare Assets
-
Our portfolio of strategic assets under the Company’s various subsidiaries was valued at
$628.4 million as ofMarch 31, 2024 , compared to$561.0 million as ofDecember 31, 2023 . In the first quarter 2024,Innoviva invested an additional$35.0 million in one of our assets, Armata, to help advance its lead therapeutic phage candidates. In addition,Innoviva invested an additional$5.8 million , with accrued interest, in Gate Neurosciences to support its strategy of developing next generation targeted CNS therapies, and an additional$2.7 million intoImaginAb Inc. to support its radiopharmaceutical platform.
Corporate Updates
-
In
April 2024 ,Derek Small , an accomplished biopharmaceutical entrepreneur and executive, joined the Company’s Board of Directors. -
Management will participate in the upcoming
Bank of America Securities Health Care Conference , taking place onMay 15, 2024 , inLas Vegas . A live webcast of the Company’s corporate presentation is scheduled for9:20 a.m. PT and can be accessed here. An archived replay will be available following the event.
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.
|
||||||||
Condensed Consolidated Statements of Income and Comprehensive Income | ||||||||
(in thousands, except per share data) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
|
||||||||
|
2024 |
|
|
2023 |
|
|||
Revenue: | ||||||||
Royalty revenue, net (1) |
$ |
58,415 |
|
$ |
56,858 |
|
||
Net product sales |
|
19,084 |
|
|
11,514 |
|
||
License Revenue |
|
- |
|
|
8,000 |
|
||
Total revenue |
|
77,499 |
|
|
76,372 |
|
||
Expenses: | ||||||||
Cost of products sold (inclusive of amortization of inventory fair value adjustments) |
|
10,971 |
|
|
8,749 |
|
||
Cost of license revenue |
|
- |
|
|
1,600 |
|
||
Selling, general and administrative |
|
30,405 |
|
|
19,735 |
|
||
Research and development |
|
3,878 |
|
|
12,588 |
|
||
Amortization of acquired intangible assets |
|
6,440 |
|
|
3,805 |
|
||
Changes in fair values of equity method investments, net |
|
(35,342 |
) |
|
(15,817 |
) |
||
Changes in fair values of equity and long-term investments, net |
|
13,335 |
|
|
2,164 |
|
||
Interest and dividend income |
|
(4,399 |
) |
|
(3,365 |
) |
||
Interest expense |
|
5,851 |
|
|
4,427 |
|
||
Other expense, net |
|
1,236 |
|
|
1,346 |
|
||
Total expenses |
|
32,375 |
|
|
35,232 |
|
||
Income before income taxes |
|
45,124 |
|
|
41,140 |
|
||
Income tax expense |
|
8,592 |
|
|
6,275 |
|
||
Net income and comprehensive income |
$ |
36,532 |
|
$ |
34,865 |
|
||
Net income per share | ||||||||
Basic |
$ |
0.58 |
|
$ |
0.51 |
|
||
Diluted |
$ |
0.46 |
|
$ |
0.42 |
|
||
Shares used to compute net income per share | ||||||||
Basic |
|
63,185 |
|
|
67,786 |
|
||
Diluted |
|
84,531 |
|
|
89,788 |
|
(1) Total net revenue is comprised of the following (in thousands): | ||||||||
Three Months Ended | ||||||||
|
||||||||
|
2024 |
|
|
2023 |
|
|||
(unaudited) | ||||||||
Royalties |
$ |
61,871 |
|
$ |
60,314 |
|
||
Amortization of capitalized fees |
|
(3,456 |
) |
|
(3,456 |
) |
||
Royalty revenue, net |
$ |
58,415 |
|
$ |
56,858 |
|
||
|
|||||
Condensed Consolidated Balance Sheets | |||||
(in thousands) | |||||
(unaudited) | |||||
|
|
||||
2024 |
2023 |
||||
Assets | |||||
Cash and cash equivalents |
$ |
178,357 |
$ |
193,513 |
|
Royalty and product sale receivables |
|
76,010 |
|
84,075 |
|
Inventory, net |
|
37,437 |
|
40,737 |
|
Prepaid expense and other current assets |
|
19,538 |
|
25,894 |
|
Property and equipment, net |
|
324 |
|
483 |
|
Equity and long-term investments |
|
628,437 |
|
560,978 |
|
Capitalized fees |
|
80,328 |
|
83,784 |
|
Right-of-use assets |
|
2,269 |
|
2,536 |
|
|
|
17,905 |
|
17,905 |
|
Intangible assets |
|
223,895 |
|
230,335 |
|
Other assets |
|
3,112 |
|
3,267 |
|
Total assets |
$ |
1,267,612 |
$ |
1,243,507 |
|
Liabilities and stockholders’ equity | |||||
Other current liabilities |
$ |
28,059 |
$ |
33,435 |
|
Accrued interest payable |
|
833 |
|
3,422 |
|
Deferred revenues |
|
987 |
|
1,277 |
|
Convertible senior notes, due 2025, net |
|
191,476 |
|
191,295 |
|
Convertible senior notes, due 2028, net |
|
255,283 |
|
254,939 |
|
Other long term liabilities |
|
71,686 |
|
71,870 |
|
Deferred tax liabilities |
|
3,807 |
|
563 |
|
Income tax payable - long term |
|
11,800 |
|
11,751 |
|
|
|
703,681 |
|
674,955 |
|
Total liabilities and stockholders’ equity |
$ |
1,267,612 |
$ |
1,243,507 |
|
|
|||||||
Cash Flows Summary | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
Three Months Ended |
|||||||
|
2024 |
|
|
2023 |
|
||
Net cash provided by operating activities |
$ |
37,047 |
|
$ |
25,684 |
|
|
Net cash used in investing activities |
|
(43,038 |
) |
|
(35,722 |
) |
|
Net cash used in financing activities |
|
(9,165 |
) |
|
(136,962 |
) |
|
Net change |
$ |
(15,156 |
) |
$ |
(147,000 |
) |
|
Cash and cash equivalents at beginning of period |
|
193,513 |
|
|
291,049 |
|
|
Cash and cash equivalents at end of period |
$ |
178,357 |
|
$ |
144,049 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508594441/en/
Corporate Communications
(908) 421-5971
david.patti@inva.com
Investors and Media:
(212) 600-1902
innoviva@argotpartners.com
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