Form 8-K

8-K — Innoviva, Inc.

Accession: 0001193125-26-335192

Filed: 2026-08-05

Period: 2026-08-05

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): August 5, 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 August 5, 2026, Innoviva, Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended June 30, 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 August 5, 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: August 5, 2026

By:

/s/ Pavel Raifeld

Pavel Raifeld

Chief Executive Officer

- 3 -

EX-99.1

Filename: d228097dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

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

IST achieved U.S. net product sales of $36.6 million in the second quarter, representing 26% year-over-year growth

Royalties portfolio generated $59.8 million in second quarter revenue

Launch of wholly-owned Strategic Healthcare Asset, Nortiva Bio, focused on novel extended-release drug delivery technology

BURLINGAME, Calif. – Aug 5, 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 second quarter ended June 30, 2026, and highlighted select corporate progress and achievements.

“Innoviva

delivered another strong quarter, supported by durable cash generation from our royalty portfolio and continued excellent commercial momentum at IST, which achieved 46% year-over-year net product sales growth, including 26% growth in U.S. sales. We

remain on track to achieve at least $150 million in IST U.S. net product sales in 2026, reflecting the differentiation of our marketed critical care and infectious disease portfolio and robust execution,” said Pavel Raifeld, Chief

Executive Officer of Innoviva.

“Recently, we also advanced several growth opportunities. This quarter, we announced a commercialization and

licensing agreement with Dr. Reddy’s Laboratories, expanding access to our top-performing antibiotic, XACDURO, in emerging markets. Additionally, we launched Nortiva Bio, a novel platform for

long-acting oral medicine delivery, with large upside potential.”

“Overall, we have been pleased with progress across our healthcare asset

portfolio, despite market volatility. Our continued activity under the share repurchase program reflects our sustained conviction in the long-term prospects of our diversified business model — one that combines durable cash generation, strong

operating revenue growth, and value creation in high-potential strategic opportunities.”

Financial Highlights for the Second Quarter of 2026

•

Total revenue: $119.6 million, representing 19% year-on-year

growth compared to $100.3 million for the second quarter of 2025.

•

Royalty revenue: gross royalty revenue from Glaxo Group

Limited (“GSK”) remains stable at $59.8 million in the second quarter of 2026, a 2% increase compared to $58.6 million in the first quarter of 2026.

•

Net product sales: $51.8 million ($36.6 million U.S. and $15.2 million ex-U.S.), representing 46% growth compared to $35.5 million in the second quarter of 2025. U.S. net product sales primarily consisted of $21.0 million from GIAPREZA®, $12.0 million from XACDURO®, and $3.3 million from XERAVA®.

•

Income from operations: $50.9 million, compared to $48.8 million for the second quarter of

2025, reflecting higher net product sales and continued operating discipline.

•

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

investments totaled $161.0 million, primarily attributable to a lower share price of Armata Pharmaceuticals. Innoviva’s strategic healthcare investments were valued at $669.5 million as of June 30, 2026, and

consisted of $457.7 million in Armata Pharmaceuticals, $177.3 million in other strategic equity and convertible debt, and $34.5 million held by ISP Fund.

•

Net income: net loss of $83.4 million, or $1.14 basic loss per share, driven primarily by

decrease in fair value of equity and long-term investments.

•

Cash and cash equivalents: Totaled $570.4 million. Royalty and net product sales

receivables totaled $110.6 million as of June 30, 2026, a 25% year-on-year increase compared to $88.3 million for the second quarter of 2025.

Key Business and R&D Highlights

•

XACDURO® (sulbactam for injection;

durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

(HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

•

During the second quarter, IST entered into an exclusive distribution and licensing agreement with

Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, for the development and commercialization of XACDURO® in South and Central America, the Caribbean, Russia and

Commonwealth of Independent States countries.

•

Strategic Healthcare Assets

•

During the second quarter, Innoviva launched Nortiva Bio (a wholly owned subsidiary), to advance the proprietary

LYNX™ long-acting oral drug delivery platform. The LYNX platform is designed to transform daily oral medicines into less frequent dosing regimens, including once-weekly or once-monthly

therapies. The platform is designed to improve patient adherence, stabilize drug exposure, and enhance clinical and commercial value by enabling less frequent oral dosing.

•

Nortiva is advancing a lead once-monthly oral drug therapy development program (via support from the Gates

Foundation) and building an external partnering pipeline to enable the development of long-acting oral versions of branded and generic therapies.

•

Capital Allocation

•

During the second quarter of 2026, Innoviva repurchased 1,403,247 shares for $31.4 million under its

$125 million share repurchase program. Since inception, and through the end of the second quarter, the Company has repurchased 2,602,168 shares for $56.4 million, reflecting the Company’s continued confidence in its intrinsic value

and long-term outlook.

•

During the second quarter of 2026, Innoviva continued to support companies in its strategic healthcare asset

portfolio with $55.0 million aggregate capital commitment.

- 2 -

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 (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

- 3 -

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.

- 4 -

INNOVIVA, INC.

Condensed Consolidated Statements of Income

(in thousands, except per share data)

(Unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Revenue:

Royalty revenue, net (1)

56,334

63,880

111,501

121,687

Net product sales

51,771

35,493

93,142

65,772

License and other revenue

11,486

910

12,942

1,456

Total revenue

119,591

100,283

217,585

188,915

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

22,349

10,590

37,956

19,432

Amortization of acquired intangible assets

6,626

6,547

13,180

13,022

Gross profit

90,616

83,146

166,449

156,461

Operating expenses:

Selling, general and administrative

34,571

26,412

67,009

53,903

Research and development

5,190

7,983

10,431

12,379

Total operating expenses

39,761

34,395

77,440

66,282

Income from operations

50,855

48,751

89,009

90,179

Changes in fair values of equity method investments, net

(131,834

)

13,082

25,816

(467

)

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

(29,153

)

11,280

4,422

(54,019

)

Interest and dividend income

7,599

4,925

18,586

9,463

Interest expense

(5,472

)

(4,663

)

(10,909

)

(9,374

)

Other expense, net

(15

)

(777

)

(381

)

(1,773

)

Income (loss) before income taxes

(108,020

)

72,598

126,543

34,009

Income tax benefit (expense)

24,600

(8,910

)

(23,368

)

(16,905

)

Net income (loss)

(83,420

)

63,688

103,175

17,104

Net income (loss) per share:

Basic

(1.14

)

1.01

1.40

0.27

Diluted

(1.14

)

0.77

1.25

0.24

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

Basic

73,421

62,865

73,789

62,787

Diluted

73,421

84,452

84,529

84,342

(1) Total net revenue is comprised of the following (in

thousands):

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

(unaudited)

Royalties

59,790

67,336

118,413

128,599

Amortization of capitalized fees

(3,456

)

(3,456

)

(6,912

)

(6,912

)

Royalty revenue, net

56,334

63,880

111,501

121,687

- 5 -

INNOVIVA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

June 30,

2026

December 31,

2025

Assets

Cash and cash equivalents

570,388

550,941

Royalty and product sale receivables

110,616

93,317

Inventory

38,968

39,172

Prepaid expense and other current assets

24,726

28,358

Current portion of ISP Fund investments

8,668

15,727

Property and equipment, net

2,133

1,555

Equity method and equity and long-term investments

660,850

598,223

Capitalized fees

49,226

56,138

Right-of-use

assets

10,377

10,929

Goodwill

17,905

Intangible assets

168,976

182,156

Other assets

39,894

40,744

Total assets

1,702,727

1,635,165

Liabilities and stockholders’ equity

Other current liabilities

39,431

43,808

Accrued interest payable

1,618

Deferred revenue

6,015

4,270

Convertible senior notes, due 2028, net

258,454

257,731

Deferred tax liabilities, net

36,739

31,793

Income tax payable, long term

59,932

57,013

Other long term liabilities

67,276

66,091

Stockholders’ equity

1,233,262

1,172,841

Total liabilities and stockholders’ equity

1,702,727

1,635,165

- 6 -

INNOVIVA, INC.

Cash Flows Summary

(in thousands)

(unaudited)

Six Months Ended June 30,

2026

2025

Net cash provided by operating activities

87,254

92,690

Net cash used in investing activities

(18,256

)

(1,552

)

Net cash provided by (used in) financing activities

(49,551

)

1,430

Net change

19,447

92,568

Cash and cash equivalents at beginning of period

550,941

304,964

Cash and cash equivalents at end of period

570,388

397,532

- 7 -

Investors and media contact

Irwin Tendler

Head of Investor Relations

Executive Director, Corporate Development

investors.relations@inva.com

- 8 -

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration