Full Press Release Details
Innoviva Reports First Quarter 2025 Financial
Results; Highlights Recent Company Progress
Core royalty platform maintained strong performance,
generating $61.3 million in revenue
Therapeutics achieved U.S. net product sales of $26.4 million for the first quarter, reflecting 52% year-over-year
across therapeutics platform with regulatory submissions for zoliflodacin and commercial launch of ZEVTERA (ceftobiprole)
progressing as planned
Calif. - May 7, 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 first quarter ended March 31,
2025, and highlighted select corporate progress and achievements.
are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued
excellent growth from the IST-marketed products," said Pavel Raifeld, Chief Executive Officer of Innoviva. "Our therapeutics
business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA (ceftobiprole)
anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating
"Additionally, we remain
dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increasing
market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions
us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,"
concluded Mr. Raifeld.
Financial Highlights
Key Business and R&D
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 commercial and marketed products include infectious disease and critical care assets: GIAPREZA
(angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA (eravacycline),
approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO (sulbactam for injection;
durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter
in adults. In addition, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized
by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., ("Basilea"), entered into in
December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for
uncomplicated gonorrhea.
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 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, 2024 and subsequently 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.
| INNOVIVA, INC. | ||||||||
| Condensed Consolidated Statements of Income | ||||||||
| (in thousands, except per share data) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Royalty revenue, net (1) | $ | 57,807 | $ | 58,415 | ||||
| Net product sales | 30,279 | 19,084 | ||||||
| License and other revenue | 546 | - | ||||||
| Total revenue | 88,632 | 77,499 | ||||||
| Cost of products sold (inclusive of amortization of inventory fair value adjustments) | 8,842 | 10,971 | ||||||
| Amortization of acquired intangible assets | 6,475 | 6,440 | ||||||
| Gross profit | 73,315 | 60,088 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 27,491 | 30,405 | ||||||
| Research and development | 4,396 | 3,878 | ||||||
| Total operating expenses | 31,887 | 34,283 | ||||||
| Income from operations | 41,428 | 25,805 | ||||||
| Changes in fair values of equity method investments, net | (13,549 | ) | 35,342 | |||||
| Changes in fair values of equity and long-term investments, net | (65,299 | ) | (13,335 | ) | ||||
| Interest and dividend income | 4,538 | 4,399 | ||||||
| Interest expense | (4,711 | ) | (5,851 | ) | ||||
| Other expense, net | (996 | ) | (1,236 | ) | ||||
| Income (loss) before income taxes | (38,589 | ) | 45,124 | |||||
| Income tax expense | (7,995 | ) | (8,592 | ) | ||||
| Net income (loss) | $ | (46,584 | ) | $ | 36,532 | |||
| Net income (loss) per share: | ||||||||
| Basic | $ | (0.74 | ) | $ | 0.58 | |||
| Diluted | $ | (0.74 | ) | $ | 0.46 | |||
| Shares used to compute net income (loss) per share: | ||||||||
| Basic | 62,709 | 63,185 | ||||||
| Diluted | 62,709 | 84,531 |
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| (unaudited) | ||||||||
| Royalties | $ | 61,263 | $ | 61,871 | ||||
| Amortization of capitalized fees | (3,456 | ) | (3,456 | ) | ||||
| Royalty revenue, net | $ | 57,807 | $ | 58,415 |
| INNOVIVA, INC. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 319,090 | $ | 304,964 | ||||
| Royalty and product sale receivables | 77,936 | 86,366 | ||||||
| Inventory, net | 41,479 | 33,725 | ||||||
| Prepaid expense and other current assets | 15,727 | 21,719 | ||||||
| Current portion of ISP Fund investments | 127,790 | 107,532 | ||||||
| Property and equipment, net | 483 | 514 | ||||||
| Equity method and equity and long-term investments | 329,844 | 393,957 | ||||||
| Capitalized fees | 66,505 | 69,961 | ||||||
| Right-of-use assets | 2,110 | 2,453 | ||||||
| Goodwill | 17,905 | 17,905 | ||||||
| Intangible assets | 201,958 | 208,433 | ||||||
| Deferred tax assets | 12,294 | 12,054 | ||||||
| Other assets | 41,269 | 41,477 | ||||||
| Total assets | $ | 1,254,390 | $ | 1,301,060 | ||||
| Liabilities and stockholders' equity | ||||||||
| Other current liabilities | $ | 40,695 | $ | 39,507 | ||||
| Accrued interest payable | 833 | 3,422 | ||||||
| Deferred revenues | 1,002 | 1,126 | ||||||
| Convertible senior notes, due 2025, net | 192,215 | 192,028 | ||||||
| Convertible senior notes, due 2028, net | 256,670 | 256,316 | ||||||
| Other long term liabilities | 62,009 | 64,275 | ||||||
| Income tax payable - long term | 54,061 | 53,227 | ||||||
| Innoviva stockholders' equity | 646,905 | 691,159 | ||||||
| Total liabilities and stockholders' equity | $ | 1,254,390 | $ | 1,301,060 |
| INNOVIVA, INC. | ||||||||
| Cash Flows Summary | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net cash provided by operating activities | $ | 48,617 | $ | 37,047 | ||||
| Net cash used in investing activities | (34,674 | ) | (43,038 | ) | ||||
| Net cash provided by (used in) financing activities | 183 | (9,165 | ) | |||||
| Net change | $ | 14,126 | $ | (15,156 | ) | |||
| Cash and cash equivalents at beginning of period | 304,964 | 193,513 | ||||||
| Cash and cash equivalents at end of period | $ | 319,090 | $ | 178,357 |
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