Full Press Release Details
Fourth Quarter and Full Year 2024 Financial Results; Highlights Recent Company Progress
Core royalty platform continues to deliver
with GSK royalties of $66.0 million for the fourth quarter and $255.6 million for the full year
Innoviva Specialty Therapeutics achieved U.S. net
product sales of $24.9 million for the fourth quarter and $80.9 million for the full year, reflecting 47% year-over-year growth
Therapeutics platform strengthened with acquisition
of exclusive U.S. commercialization and distribution rights to ZEVTERA (ceftobiprole), launching mid-2025
Calif. - February 26, 2025 - Innoviva, Inc. (NASDAQ: INVA) ("Innoviva" or the "Company"),
a diversified holding company with a core royalties portfolio, a leading
critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"),
and a portfolio of strategic investments in healthcare assets, today reported financial results for the fourth quarter and full year
ended December 31, 2024, and highlighted select corporate progress and achievements.
Raifeld, Chief Executive Officer of Innoviva, said: "2024 was an exceptional year for Innoviva. Our core royalty portfolio and
therapeutics business both delivered strong year-over-year revenue growth. The excellent performance of IST in 2024 -
including revenue growth, new product acquisition through partnership, and significant pipeline progress - is a clear
validation of our strategy to build a leading commercial business in critical care and infectious disease."
continued, "In 2024, IST's revenue growth was driven by the successful launch of XACDURO and a renewed commercial
strategy unlocking new opportunities for GIAPREZA . Additionally, both XACDURO and XERAVA received favorable guidelines
placement, which has helped increase access to patients. We also added a fourth approved product to our leverageable commercial infrastructure
by licensing ZEVTERA in the U.S., showcasing both our potential to be a preferred commercial partner and the value creation opportunities
enabled by the strength of our operating platform."
ahead, we anticipate another strong year in 2025 highlighted by an NDA submission for zoliflodacin, the launch of ZEVTERA in
mid-2025, and continued growth of our marketed products, with U.S. net product sales forecasted to exceed $100 million. Backed by
nearly $400 million cash and receivables, Innoviva is a well-capitalized company focused on continued value creation through
disciplined capital deployment and operational excellence," concluded Mr. Raifeld.
Financial Highlights
Update on Strategic Healthcare Assets
Innoviva is a diversified holding company
with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"),
and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered
with Glaxo Group Limited ("GSK"). Innoviva is entitled to receive royalties from GSK on sales of RELVAR /BREO ELLIPTA and
ANORO ELLIPTA . Innoviva's other innovative healthcare assets include infectious disease and
critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO (sulbactam for injection;
durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia
and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and
the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical
Company, including GIAPREZA (angiotensin II), approved to increase blood pressure in adults with septic or other
distributive shock and XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections in adults.
On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd,
Allschwil for the commercialization of ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S.
BREO are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil.
Forward Looking Statements
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. Innoviva intends
such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words "anticipate",
"expect", "goal", "intend", "objective", "opportunity", "plan",
"potential", "target" and similar expressions are intended to identify such forward-looking statements. Such
forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates
and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks,
uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be
materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower
than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR /BREO ELLIPTA ,
ANORO ELLIPTA , GIAPREZA , XERAVA , XACDURO and
ZEVTERA in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including
Innoviva's growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns
to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms
of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory
approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus ("COVID-19");
the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company's
growth strategy. Other risks affecting Innoviva are described under the headings "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K
for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q, which are on file with the Securities
and Exchange Commission ("SEC") and available on the SEC's website at www.sec.gov. Past performance
is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially
from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information
in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking
statements on account of new information, future events or otherwise, except as required by law.
Condensed Consolidated Statements of Income
(in thousands, except per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| Royalty revenue, net (1) | $ | 62,520 | $ | 66,165 | $ | 241,733 | $ | 238,846 | ||||||||
| Net product sales | 28,935 | 19,675 | 97,492 | 60,617 | ||||||||||||
| License Revenue | 351 | - | 19,486 | 11,000 | ||||||||||||
| Total revenue | 91,806 | 85,840 | 358,711 | 310,463 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of products sold (inclusive of amortization of inventory fair value adjustments) | 7,165 | 13,130 | 36,598 | 41,040 | ||||||||||||
| Cost of license revenue | - | - | - | 1,600 | ||||||||||||
| Selling, general and administrative | 31,326 | 26,319 | 115,690 | 98,232 | ||||||||||||
| Research and development | 3,665 | 2,356 | 13,654 | 33,922 | ||||||||||||
| Amortization of acquired intangible assets | 6,511 | 6,510 | 25,902 | 21,784 | ||||||||||||
| Changes in fair values of equity method investments, net | 21,256 | (9,506 | ) | 64,253 | (77,392 | ) | ||||||||||
| Changes in fair values of equity and long-term investments, net | (1,666 | ) | (16,016 | ) | 59,161 | (11,129 | ) | |||||||||
| Interest and dividend income | (5,768 | ) | (4,786 | ) | (19,141 | ) | (15,818 | ) | ||||||||
| Interest expense | 4,749 | 5,952 | 22,209 | 19,157 | ||||||||||||
| Other expense (income), net | (126 | ) | 680 | 2,997 | 4,969 | |||||||||||
| Total expenses | 67,112 | 24,639 | 321,323 | 116,365 | ||||||||||||
| Income before income taxes | 24,694 | 61,201 | 37,388 | 194,098 | ||||||||||||
| Income tax expense | 4,362 | (330 | ) | 13,996 | 14,376 | |||||||||||
| Net income | 20,332 | 61,531 | 23,392 | 179,722 | ||||||||||||
| Net income per share | ||||||||||||||||
| Basic net income per share attributable to Innoviva stockholders | $ | 0.32 | $ | 0.97 | $ | 0.37 | $ | 2.75 | ||||||||
| Diluted net income per share attributable to Innoviva stockholders | $ | 0.26 | $ | 0.76 | $ | 0.36 | $ | 2.20 | ||||||||
| Shares used to compute basic net income per share | 62,626 | 63,710 | 62,726 | 65,435 | ||||||||||||
| Shares used to compute diluted net income per share | 84,200 | 84,995 | 74,187 | 86,876 |
(1) Total net revenue is comprised of the following (in thousands):
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Royalties | $ | 65,975 | $ | 69,620 | $ | 255,556 | $ | 252,669 | ||||||||
| Amortization of capitalized fees | (3,455 | ) | (3,455 | ) | (13,823 | ) | (13,823 | ) | ||||||||
| Royalty revenue, net | $ | 62,520 | $ | 66,165 | $ | 241,733 | $ | 238,846 |
Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 304,964 | $ | 193,513 | ||||
| Royalty and product sale receivables | 86,366 | 84,075 | ||||||
| Inventory, net | 33,725 | 40,737 | ||||||
| Prepaid expense and other current assets | 21,719 | 25,894 | ||||||
| Current portion of ISP Fund investments | 107,532 | - | ||||||
| Property and equipment, net | 514 | 483 | ||||||
| Equity and long-term investments | 393,957 | 560,978 | ||||||
| Capitalized fees | 69,961 | 83,784 | ||||||
| Right-of-use assets | 2,453 | 2,536 | ||||||
| Goodwill | 17,905 | 17,905 | ||||||
| Intangible assets | 208,433 | 230,335 | ||||||
| Deferred tax assets | 12,054 | - | ||||||
| Other assets | 41,477 | 3,267 | ||||||
| Total assets | $ | 1,301,060 | $ | 1,243,507 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 39,507 | $ | 33,435 | ||||
| Accrued interest payable | 3,422 | 3,422 | ||||||
| Deferred revenues | 1,126 | 1,277 | ||||||
| Convertible senior notes, due 2025, net | 192,028 | 191,295 | ||||||
| Convertible senior notes, due 2028, net | 256,316 | 254,939 | ||||||
| Other long term liabilities | 64,275 | 71,870 | ||||||
| Deferred tax liabilities | - | 563 | ||||||
| Income tax payable - long term | 53,227 | 11,751 | ||||||
| Innoviva stockholders' equity | 691,159 | 674,955 | ||||||
| Total liabilities and stockholders' equity | $ | 1,301,060 | $ | 1,243,507 |
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Net cash provided by operating activities | $ | 188,690 | $ | 141,064 | ||||
| Net cash used in investing activities | (63,786 | ) | (66,761 | ) | ||||
| Net cash used in financing activities | (13,453 | ) | (171,839 | ) | ||||
| Net change | $ | 111,451 | $ | (97,536 | ) | |||
| Cash and cash equivalents at beginning of period | 193,513 | 291,049 | ||||||
| Cash and cash equivalents at end of period | $ | 304,964 | $ | 193,513 |
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