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 |