8-K
false 0001080014 0001080014 2026-08-05 2026-08-05
 
 

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)

 

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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

 

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EX-99.1

Exhibit 99.1

 

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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.


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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.

 

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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

 

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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.

 

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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)     (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  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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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        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        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  
  

 

 

    

 

 

 

 

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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  
  

 

 

   

 

 

 

 

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Investors and media contact

Irwin Tendler

Head of Investor Relations

Executive Director, Corporate Development

investors.relations@inva.com

 

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