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Innoviva Reports Second Quarter 2025 Financial Results; Highlights Recent Company Progress Strong royalties portfolio performance with $67.3 million in revenue IST achieved U.S. net product sales of $29.0 million, reflec

Key Takeaway: Innoviva Reports Second Quarter 2025 Financial Results; Highlights Recent Company Progress Strong royalties portfolio performance with $67.3 IST achieved U.S. net product sales of $29.0 million, reflecting 54% year-over-year growth ZEVTERA (ceftobiprole medocaril sodium, fo

Full Press Release Details

Innoviva Reports Second Quarter 2025 Financial
Results; Highlights Recent Company Progress
Strong royalties portfolio performance with $67.3
IST achieved U.S. net
product sales of $29.0 million, reflecting 54% year-over-year growth
ZEVTERA (ceftobiprole
medocaril sodium, for injection) launched in the U.S.
Zoliflodacin NDA accepted
by FDA with Priority Review; PDUFA date set for December 15, 2025
Calif. - August 6, 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 second quarter ended June 30, 2025,
and highlighted select corporate progress and achievements.
continued to deliver impressive financial and operational results last quarter, represented by strong performance from our GSK royalties
portfolio, combined with significant momentum from our IST-marketed products. We successfully launched our fourth product, ZEVTERA,
the first and only FDA-approved cephalosporin for MRSA-related Staphylococcus aureus bacteremia, in the U.S., and we are pleased
with the market engagement," said Pavel Raifeld, Chief Executive Officer of Innoviva. "The FDA's
acceptance of the zoliflodacin NDA and granting of Priority Review mark critical regulatory milestones for this important product.
We will be working diligently with the FDA toward the PDUFA target action date of December 15, 2025. If approved, single-dose oral
zoliflodacin could be the first new antibiotic in decades for the treatment of gonorrhea. I believe recent advances attest to the success
of our efforts to build a best-in-class business in the infectious disease and critical care space. We are also pleased with excellent
progress across our strategic healthcare asset portfolio, including Armata Pharmaceuticals' recently announced positive Phase 2
data in Staphylococcus aureus bacteremia."
Mr. Raifeld continued, "Our dynamic, well-capitalized business has proven to be resilient, despite significant external volatility, and
we see multiple opportunities to create value in the current market environment through thoughtful capital allocation."
Financial Highlights
Key Business and R&D
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. Innoviva also
markets ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea
Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to www.innoviva.com. For information about Innoviva
Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com.
and BREO are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil.
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. 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.
Corporate Communications
Condensed Consolidated Statements of Income
(in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2025 2024 2025 2024
Revenue:
Royalty revenue, net (1) $ 63,880 $ 63,742 $ 121,687 $ 122,157
Net product sales 35,493 21,651 65,772 40,735
License and other revenue 910 14,505 1,456 14,505
Total revenue 100,283 99,898 188,915 177,397
Cost of products sold
(inclusive of amortization of inventory fair value adjustments) 10,590 8,472 19,432 19,443
Amortization of acquired intangible assets 6,547 6,440 13,022 12,880
Gross profit 83,146 84,986 156,461 145,074
Operating expenses:
Selling, general and administrative 26,412 27,740 53,903 58,145
Research and development 7,983 2,560 12,379 6,438
Total operating expenses 34,395 30,300 66,282 64,583
Income from operations 48,751 54,686 90,179 80,491
Changes in fair values of equity method investments, net 13,082 (60,108 ) (467 ) (24,766 )
Changes in fair values of equity and long-term investments, net 11,280 (30,556 ) (54,019 ) (43,891 )
Interest and dividend income 4,925 3,474 9,463 7,873
Interest expense (4,663 ) (5,802 ) (9,374 ) (11,653 )
Other expense, net (777 ) (973 ) (1,773 ) (2,209 )
Income (loss) before income taxes 72,598 (39,279 ) 34,009 5,845
Income tax expense (8,910 ) 4,594 (16,905 ) (3,998 )
Net income (loss) $ 63,688 $ (34,685 ) $ 17,104 $ 1,847
Net income (loss) per share:
Basic $ 1.01 $ (0.55 ) $ 0.27 $ 0.03
Diluted $ 0.77 $ (0.55 ) $ 0.24 $ 0.03
Shares used to compute net income (loss) per share:
Basic 62,865 62,526 62,787 62,856
Diluted 84,452 62,526 84,342 63,064
(1) Total net revenue is comprised of the following (in thousands):
Three Months Ended Six Months Ended
June 30, June 30,
2025 2024 2025 2024
(unaudited) (unaudited)
Royalties $ 67,336 $ 67,198 $ 128,599 $ 129,069
Amortization of capitalized fees (3,456 ) (3,456 ) (6,912 ) (6,912 )
Royalty revenue, net $ 63,880 $ 63,742 $ 121,687 $ 122,157
Condensed Consolidated Balance Sheets
June 30, December 31,
2025 2024
Assets
Cash and cash equivalents $ 397,532 $ 304,964
Royalty and product sale receivables 88,261 86,366
Inventory, net 48,996 33,725
Prepaid expense and other current assets 16,791 21,719
Current portion of ISP Fund investments 100,198 107,532
Property and equipment, net 451 514
Equity method and equity and long-term investments 349,110 393,957
Capitalized fees 63,049 69,961
Right-of-use assets 1,759 2,453
Goodwill 17,905 17,905
Intangible assets 195,411 208,433
Deferred tax assets 12,931 12,054
Other assets 41,178 41,477
Total assets $ 1,333,572 $ 1,301,060
Liabilities and stockholders' equity
Other current liabilities $ 48,117 $ 39,507
Accrued interest payable 3,418 3,422
Deferred revenues 3,125 1,126
Convertible senior notes, due 2025, net 191,903 192,028
Convertible senior notes, due 2028, net 257,019 256,316
Other long term liabilities 60,021 64,275
Income tax payable - long term 55,148 53,227
Innoviva stockholders' equity 714,821 691,159
Total liabilities and stockholders' equity $ 1,333,572 $ 1,301,060
Six Months Ended June 30,
2025 2024
Net cash provided by operating activities $ 92,690 $ 80,765
Net cash used in investing activities (1,552 ) (43,038 )
Net cash provided by (used in) financing activities 1,430 (14,237 )
Net change $ 92,568 $ 23,490
Cash and cash equivalents at beginning of period 304,964 193,513
Cash and cash equivalents at end of period $ 397,532 $ 217,003
Last updated: Aug 6, 2025