Form 8-K

8-K — Innoviva, Inc.

Accession: 0001193125-26-209044

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0001080014

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 6, 2026

INNOVIVA, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

000-30319

94-3265960

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification Number)

1350 Old Bayshore Highway,

Suite 400

Burlingame, California 94010

(650) 238-9600

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.01 per share

INVA

The NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition

On May 6, 2026, Innoviva, Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

99.1

Press Release dated May 6, 2026

104

Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document)

-2-

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

INNOVIVA, INC.

Date: May 6, 2026

By:

/s/ Pavel Raifeld

Pavel Raifeld

Chief Executive Officer

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EX-99.1

Filename: d54063dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Innoviva Reports First Quarter 2026 Financial Results; Highlights Recent Company Progress

Generated $58.6 million in revenue from resilient royalties portfolio

Achieved IST U.S. net product sales of $34.2 million for the first quarter, representing 29% year-over-year growth

Significant value created across strategic healthcare asset portfolio

BURLINGAME, Calif. – May 6, 2026 – Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the

“Company”), a diversified biopharmaceutical 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, 2026, and highlighted select corporate progress and achievements.

“We delivered a strong start to 2026, driven by the resilience of our royalty portfolio, continued excellent commercial progress at IST, and meaningful

value creation across our strategic healthcare assets,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “IST achieved 37% year-over-year net product sales growth in the first quarter of 2026, including 29% growth in U.S.

sales.”

“We also remained active in executing our capital allocation priorities, including increased activity under our $125 million

share repurchase program, underscoring our confidence in Innoviva’s long-term value proposition. Innoviva’s strong track record across its operating and strategic healthcare assets, coupled with significant cash resources and durable

royalty inflows, positions us well for accretive capital deployment and long-term shareholder value creation throughout variable market environments,” concluded Mr. Raifeld.

Financial Highlights for the First Quarter of 2026

•

Total revenue: $98.0 million, yielding 11% growth compared to $88.6 million for the first

quarter 2025.

•

Royalty revenue: gross royalty revenue from Glaxo Group Limited (“GSK”)

was $58.6 million, compared to $61.3 million for the first quarter 2025.

•

Net product sales: $41.4 million ($34.2 million U.S. and $7.2 million ex-US), representing 37% growth compared to $30.3 million in the same quarter of 2025. U.S. net product sales primarily consisted of $19.7 million from

GIAPREZA®, $11.6 million from XACDURO®, and $2.5 million from

XERAVA®.

•

Income from operations: $38.2 million, compared to $41.4 million for the first quarter

2025, reflecting continued investment in commercial activities, as well as product and business development.

•

Equity and long-term investments: net favorable changes in fair value of equity and long-term

investments totaled $191.2 million, primarily attributable to share price appreciation of Armata Pharmaceuticals. Innoviva’s strategic healthcare investments were valued at $773.3 million as of March 31, 2026, and consisted

of $603.4 million in Armata Pharmaceuticals, $138.2 million in other strategic equity and convertible debt, and $31.7 million held by ISP Fund.

•

Net income: $186.6 million ($2.52 basic earnings per share) was driven

primarily by higher revenue and the positive impact of changes in the fair values of equity and long-term investments.

•

Cash and cash equivalents: Totaled $603.1 million. Royalty and net product sales

receivables totaled $92.6 million as of March 31, 2026.

Key Business and R&D Highlights

•

NUZOLVENCE®

(zoliflodacin): a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae

in adults and pediatric patients 12 years and older weighing at least 35kg, developed in partnership with The Global Antibiotic Research & Development Partnership (“GARDP”).

•

In December 2025, IST received U.S. Food and Drug Administration (FDA) approval of NUZOLVENCE®, one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades.

•

The Company remains on track to make NUZOLVENCE®

available to patients in the second half of 2026.

•

Strategic healthcare assets

•

Innoviva’s strategic healthcare asset portfolio experienced meaningful growth this quarter, including

notable value crystallization at Armata Pharmaceuticals. Innoviva remains focused on disciplined capital deployment across healthcare opportunities where it believes its strategic perspective and operating experience can support long-term sustained

returns.

•

Capital Allocation

•

During the first quarter of 2026, Innoviva repurchased 971,066 shares for $20.4 million under its

$125 million share repurchase program. Since inception, and through the end of this quarter, the Company has repurchased 1,198,921 shares for $25.0 million, reflecting the Company’s continued confidence in its intrinsic value and

long-term outlook.

About Innoviva

Innoviva is a diversified biopharmaceutical 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 critical care and infectious disease assets under the IST platform include GIAPREZA® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO® (sulbactam for injection;

durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of

Acinetobacter baumannii-calcoaceticus, XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA

- 2 -

(ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and

NUZOLVENCE® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg.

For more information about Innoviva, go to www.inva.com. For information about Innoviva Specialty Therapeutics, go to www.innovivaspecialtytherapeutics.com.

ANORO®, RELVAR® 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®, ZEVTERA® and NUZOLVENCE® 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 development of the LYNX® platform; 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, 2025 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.

- 3 -

INNOVIVA, INC.

Condensed Consolidated Statements of Income

(in thousands, except per share data)

(Unaudited)

Three Months Ended

March 31,

2026

2025

Revenue:

Royalty revenue, net (1)

55,167

57,807

Net product sales

41,371

30,279

License and other revenue

1,456

546

Total revenue

97,994

88,632

Cost of products sold (inclusive of amortization of inventory fair value adjustments)

15,607

8,842

Amortization of acquired intangible assets

6,554

6,475

Gross profit

75,833

73,315

Operating expenses:

Selling, general and administrative

32,438

27,491

Research and development

5,241

4,396

Total operating expenses

37,679

31,887

Income from operations

38,154

41,428

Changes in fair values of equity method investments, net

157,650

(13,549

)

Changes in fair values of equity and long-term investments, net

33,575

(65,299

)

Interest and dividend income

10,987

4,538

Interest expense

(5,437

)

(4,711

)

Other expense, net

(366

)

(996

)

Income (loss) before income taxes

234,563

(38,589

)

Income tax expense

(47,968

)

(7,995

)

Net income (loss)

186,595

(46,584

)

Net income (loss) per share:

Basic

2.52

(0.74

)

Diluted

2.22

(0.74

)

Shares used to compute net income (loss) per share:

Basic

74,160

62,709

Diluted

84,849

62,709

(1)

Total net revenue is comprised of the following (in thousands):

Three Months Ended

March 31,

2026

2025

(unaudited)

Royalties

58,623

61,263

Amortization of capitalized fees

(3,456

)

(3,456

)

Royalty revenue, net

55,167

57,807

- 4 -

INNOVIVA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

March 31,

December 31,

2026

2025

Assets

Cash and cash equivalents

603,085

550,941

Royalty and product sale receivables

92,628

93,317

Inventory

38,843

39,172

Prepaid expense and other current assets

29,221

28,358

Current portion of ISP Fund investments

8,846

15,727

Property and equipment, net

2,142

1,555

Equity method and equity and long-term investments

764,454

598,223

Capitalized fees

52,682

56,138

Right-of-use

assets

10,652

10,929

Goodwill

17,905

Intangible assets

175,602

182,156

Other assets

40,527

40,744

Total assets

1,836,587

1,635,165

Liabilities and stockholders’ equity

Other current liabilities

32,650

43,808

Accrued interest payable

231

1,618

Deferred revenue

3,677

4,270

Convertible senior notes, due 2028, net

258,095

257,731

Deferred tax liabilities, net

72,831

31,793

Income tax payable, long term

58,345

57,013

Other long term liabilities

69,103

66,091

Stockholders’ equity

1,341,655

1,172,841

Total liabilities and stockholders’ equity

1,836,587

1,635,165

INNOVIVA, INC.

Cash Flows Summary

(in thousands)

(unaudited)

Three Months Ended March 31,

2026

2025

Net cash provided by operating activities

35,282

48,617

Net cash provided by (used in) investing activities

37,008

(34,674

)

Net cash provided by (used in) financing activities

(20,146

)

183

Net change

52,144

14,126

Cash and cash equivalents at beginning of period

550,941

304,964

Cash and cash equivalents at end of period

603,085

319,090

- 5 -

Contacts

Investor Relations (Internal):

Eleanor Barisser

Director, Investor Relations and Corporate Communications

Eleanor.barisser@inva.com

Investors and Media:

Argot Partners

(212)

600-1902

innoviva@argotpartners.com

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