Companies › INVA

INVA 10-K & 10-Q changes, risk factors and insider trading

Innoviva, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1080014 · All filings on SEC.gov

Everything below is quoted or computed from Innoviva, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

4 / 17risk-factor paragraphs added / removed in latest 10-K
0new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

Jump to: Annual report (10-K) · Quarterly report (10-Q) · Insider transactions · 13F holders

What changed in the latest 10-K

Comparing 10-K filed 2026-02-25 (period ending 2025-12-31) with 10-K filed 2025-02-26 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

4new paragraphs
17removed paragraphs
19reworded paragraphs
29,209 → 28,552words in section

Removed heading “Under the Services Agreement with Sarissa Capital, we may rely on Sarissa Capital to assist in our strategic investing activity.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text
“Under the Services Agreement with Sarissa Capital, we may rely on Sarissa Capital to assist in our strategic investing activity.”
see in full comparison
Removed text topics: litigation
“Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative impact on our ability to compete in the marketplace.”
see in full comparison
New text topics: inflation
“The Inflation Reduction Act of 2022 (“IRA”) establishes a drug price negotiation program under which the Centers for Medicare & Medicaid Services (“CMS”) is authorized to negotiate maximum fair prices (“MFPs”) for certain high-expenditure, single-source drugs reimbursed under Medicare Part D and Part B. RELVAR®/BREO® ELLIPTA® has been selected for negotiation under this program, with its negotiated MFP scheduled to take effect beginning January 1, 2027, and ANORO® ELLIPTA® has been selected in a subsequent negotiation cycle, with its negotiated MFP expected to take effect in 2028. …”
see in full comparison
Reworded topics: regulation

Paragraph as it now reads, with added and removed wording marked:

The FDA and the EMA have each established regulations to govern the product development and approval process, as have other foreign regulatory authorities. The policies of the FDA, the EMA and other regulatory authorities may change. ForIn example,the U.S., Congress has enacted significant healthcare and FDA-related legislation in December 2016,recent years, including the 21st  Century Cures Act,Act orand Curessubsequent Act,user wasfee signedreauthorization intoacts, law.and may continue to consider additional reforms affecting drug development, clinical trial requirements, approval standards, manufacturing oversight and post-approval obligations. The CuresFDA Act,has also issued numerous guidance documents and initiatives addressing, among other things, is intended to modernizetopics, the regulationuse of drugsreal-world evidence, decentralized and spurhybrid innovation,clinical buttrials, not all its provisions have yet been implemented. Additionally,diversity in August 2017, the FDA issued final guidance setting forth its current thinking with respect to development programs and clinical trial designsenrollment, fordata integrity, cybersecurity, manufacturing quality, and the development of antibacterial drugsand toantifungal treat serious bacterial diseases in patients with an unmet medical need.therapies. We cannot predict what if any effect the Cures Act or any existing or future guidance from the FDA or other regulatory authorities will have on the development of our product candidates.
see in full comparison
Reworded topics: litigation

Paragraph as it now reads, with added and removed wording marked:

In any infringement litigation, any award of monetary damages we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive because of the proceedings. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative impact on our ability to compete in the marketplace.
see in full comparison
New text topics: labor
“Our reliance on non-profit and philanthropic funding subjects us to risks outside of our control, including the availability of funding, changes in the strategic priorities of funding organizations, economic downturns affecting charitable giving, and the discontinuation or reduction of grant programs. Non-profit funders may also impose restrictions on the use, licensing, pricing, or commercialization of technologies developed with their support, which could limit our flexibility in pursuing commercial opportunities or entering into strategic collaborations. …”
see in full comparison
Full comparison: every changed paragraph (40)

Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

Our debt including our convertible subordinated notes and convertible senior notes are senior in capital structure and cash flow, respectively, to our common stockholders. Satisfying the obligations relating to our debt could adversely affect our liquidity or the amount or timing of potential distributions to our stockholders.

Reworded

If clinical trials of our and our related parties' product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, the EMA or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of that product candidate.

Reworded

Even if we complete the necessary preclinical studies and clinical trials, theThe regulatory approval process is expensive, time-consuming and uncertain and may prevent us or any future collaborators from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we, or any future collaborators, will obtain marketing approval to commercialize a product candidate.

Reworded

Currently, we derive mostthe majority of our revenues from GSK and our near-term success depends in large part on GSK’s ability to successfully develop and commercialize the products in the respiratory programs partnered with GSK.

Removed

In January 2019, Mylan announced that the FDA approved Wixela™ Inhu™ (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of ADVAIR DISKUS®. In that same month, Teva announced that the FDA approved two of their products for adolescent and adult patients with asthma, one of which is AirDuo™ RespiClick® (fluticasone propionate and salmeterol inhalation powder), a non-AB substitutable generic version of Advair®. In January 2020, Astra Zeneca launched an authorized generic version of Symbicort. In December 2020, Hikma/Vectura announced that it received FDA approval and launched its generic version of GSK’s Advair Diskus®.

Added

The Inflation Reduction Act of 2022 (“IRA”) establishes a drug price negotiation program under which the Centers for Medicare & Medicaid Services (“CMS”) is authorized to negotiate maximum fair prices (“MFPs”) for certain high-expenditure, single-source drugs reimbursed under Medicare Part D and Part B. RELVAR®/BREO® ELLIPTA® has been selected for negotiation under this program, with its negotiated MFP scheduled to take effect beginning January 1, 2027, and ANORO® ELLIPTA® has been selected in a subsequent negotiation cycle, with its negotiated MFP expected to take effect in 2028. As a result, these products will be subject to government-negotiated prices in the Medicare channel, which is expected to result in lower net realized prices relative to historical levels and may also influence pricing dynamics in the commercial market through reference pricing, formulary positioning, or other payer actions.

Reworded

We currently depend, in part, on royalties from sales of our products partnered with GSK to support our existing operations. The treatment paradigm for COPD and asthma constantly evolves. For instance, in November 2018, the GOLD guidelines were revised to favorably position bronchodilator monotherapy and LABA/LAMA treatment ahead of ICS/LABA for the treatment of COPD unless the patient has frequent exacerbations, or an eosinophil count greater than 300 per cubic microliter. The use of ICS in COPD is also recommended for patients requiring triple therapy (LABA, LAMA, ICS). If the treatment paradigms were to change further, causing our partnered products to fall out of favor, or if GSK were unable, or did not devote sufficient resources, to maintain or continue increasing RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® sales, our results of operations would likely suffer, and the price of our securities could fall.

Reworded

GSK is responsible for all clinical and other product development, regulatory, manufacturing and commercialization activities for products developed under the GSK Agreements, including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Our royalty revenues under the GSK Agreements may not meet our, analysts’, or investors’ expectations, due to a number of important factors. GSK has a substantial respiratory product portfolio in addition to the partnered products that are covered by the GSK Agreements. GSK may make respiratory product portfolio decisions or statements about its portfolio which may be, or may be perceived to be, harmful to the respiratory products partnered with us. For instance, GSK has wide discretion in determining the efforts and resources that it will apply to the development and commercialization of our partnered products. In addition, GSK may determine to focus its commercialization efforts on its own products. For example, in January 2015, GSK launched Incruse® (UMEC) in the U.S., which is a LAMA for the treatment of COPD. GSK may determine to focus its marketing efforts on Incruse, which could have the effect of decreasing the potential market share of ANORO® ELLIPTA® and lowering the royalties we may receive for such product. Alternatively, GSK may decide to market to eventually compete directly against sales of RELVAR®/BREO® ELLIPTA®. In the event GSK does not devote sufficient resources to the commercialization of our partnered products or chooses to reprioritize its commercial programs, our business, operations and stock price would be negatively affected.

Reworded

We have a significant amount of debt including our convertible subordinated notes and convertible senior notes that are senior in capital structure and cash flow, respectively, to our common stockholders. Satisfying the obligations relating to our debt could adversely affect our liquidity or the amount or timing of potential distributions to our stockholders.

Reworded

As of December 31, 2024,2025, we had $453.5$261.0 million in total debt outstanding, comprised primarily of $192.5 million in principal outstanding under our convertible senior notes due 2025 (the “2025 Notes”) and $261.0 million in principal outstanding under our convertible notes due 2028 (the “2028 Notes”) (the 2025 Notes and 2028 Notes, hereinafter, the “Notes”). The 2028 Notes are unsecured debtdebt. and, with the exceptionHolders of the 2028 Notes, are not redeemable by us prior to the maturity date. Holders of the Notes may require us to purchase all or any portion of their 2028 Notes at 100% of their principal amount, plus any unpaid interest, upon a fundamental change. A fundamental change is generally defined to include a merger involving us, an acquisition of a majority of our outstanding common stock. In addition, to the extent we pursue and complete a monetization transaction or a transaction that modifies our corporate structure, the structure of such transaction may qualify as a fundamental change under the 2028 Notes, which could trigger the put rights of the holders of the 2028 Notes, in which case we would be required to use a portion of the net proceeds from such transaction to repurchase any Notes put to us.

Reworded

Satisfying the obligations of this debt could adversely affect the amount or timing of any distributions to our stockholders. We may choose to satisfy, repurchase, or refinance this debt through public or private equity or debt financings if we deem such financings available on favorable terms. If any or all of the 2028 Notes are not converted into shares of our common stock before the maturity date, we will have to pay the holders the full aggregate principal amount of the 2028 Notes then outstanding. Any of the above payments could have a material adverse effect on our cash position. If we fail to satisfy these obligations, it may result in a default under the indenture, which could result in a default under certain of our other debt instruments, if any. Any such default would harm our business and the price of our securities could fall.

Reworded

We rely on third parties to conduct the clinical trials for our products and product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with applicable regulatory requirements.

Reworded

Our reliance on third parties to manufacture our product candidates and approved products increases the risk that we will not have sufficient quantities of our product candidates or approved products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

Reworded

We do not own or operate manufacturing facilities to produce clinical or commercial supplies of the product candidates that we are developing or evaluating.evaluating or commercial supplies of our approved products. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture any of our product candidates on a clinical scale or our approved products on a commercial scale. We currently rely on third parties for supply of our product candidates,candidates and approved products, and our strategy is to outsource all manufacturing of our product candidates and approved products, if any, to third parties.

Reworded

Our and our investees' reliance on non-profit and government funding for certain of our and our investees' programs adds uncertainty to our and our investees' research, development and commercialization efforts with respect to those programs and may impose requirements that increase the costs of the research, development and commercialization of product candidates developed under those non-profit and government-funded programs.

Removed

Aspects of certain of our development programs are currently being supported, in part, with funding from the NIH, NIAID, CARB-X and the DOD. Contracts and grants awarded by the U.S. government, its agencies and its partners, including our awards from the NIH, NIAID, CARB-X, and the DOD, include provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to:

Removed

terminate agreements, in whole or in part, for any reason or no reason at all;

Removed

provide grant support to potential competitor programs;

Removed

reduce or modify the government’s obligations under such agreements without the consent of the other party;

Removed

claim rights, including intellectual property rights, in products and data developed under such agreements;

Removed

audit contract-related costs and fees, including allocated indirect costs;

Removed

suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;

Removed

impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;

Removed

suspend or debar the contractor or grantee from doing future business with the government;

Removed

control and potentially prohibit the export of products;

Removed

pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.

Reworded

We may not have the right to prohibit the U.S. government from using certain technologies developed by us,us and our investees, and may not be able to prohibit third-party companies, including our competitors, from using those technologies in providing products and services to the U.S. government. The U.S. government generally takes the position that it has the right to royalty-free use of technologies that are developed under U.S. government contracts.

Added

In addition to government funding, we receive grants and other financial support from non-profit organizations and philanthropic funders to support our research and development activities. Such funding is typically awarded for specified research programs and is subject to milestone-based payments, reporting requirements, intellectual property restrictions, stewardship obligations, and other compliance conditions similar to those imposed under government awards. If we fail to comply with these requirements, we may be required to repay funds, become ineligible for future funding, and suffer reputational harm.

Added

Our reliance on non-profit and philanthropic funding subjects us to risks outside of our control, including the availability of funding, changes in the strategic priorities of funding organizations, economic downturns affecting charitable giving, and the discontinuation or reduction of grant programs. Non-profit funders may also impose restrictions on the use, licensing, pricing, or commercialization of technologies developed with their support, which could limit our flexibility in pursuing commercial opportunities or entering into strategic collaborations. Any reduction, delay, or termination of such funding could materially adversely affect our research programs, financial condition, and results of operations.

Reworded

In any infringement litigation, any award of monetary damages we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive because of the proceedings. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative impact on our ability to compete in the marketplace.

Removed

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative impact on our ability to compete in the marketplace.

Reworded

The FDA and the EMA have each established regulations to govern the product development and approval process, as have other foreign regulatory authorities. The policies of the FDA, the EMA and other regulatory authorities may change. ForIn example,the U.S., Congress has enacted significant healthcare and FDA-related legislation in December 2016,recent years, including the 21st  Century Cures Act,Act orand Curessubsequent Act,user wasfee signedreauthorization intoacts, law.and may continue to consider additional reforms affecting drug development, clinical trial requirements, approval standards, manufacturing oversight and post-approval obligations. The CuresFDA Act,has also issued numerous guidance documents and initiatives addressing, among other things, is intended to modernizetopics, the regulationuse of drugsreal-world evidence, decentralized and spurhybrid innovation,clinical buttrials, not all its provisions have yet been implemented. Additionally,diversity in August 2017, the FDA issued final guidance setting forth its current thinking with respect to development programs and clinical trial designsenrollment, fordata integrity, cybersecurity, manufacturing quality, and the development of antibacterial drugsand toantifungal treat serious bacterial diseases in patients with an unmet medical need.therapies. We cannot predict what if any effect the Cures Act or any existing or future guidance from the FDA or other regulatory authorities will have on the development of our product candidates.

Removed

Other federal health reform measures have been proposed and adopted in the United States. For example, the Medicare Access and CHIP Reauthorization Act of 2015 ended the use of the statutory formula for clinician payment and established a quality payment incentive program, also referred to as the Quality Payment Program. This program provides clinicians with two ways to participate, including through the Advanced Alternative Payment Models, or APMs, and the Merit-based Incentive Payment System, or MIPS. In November 2019, CMS issued a final rule finalizing the changes to the Quality Payment Program. It is unclear how payment reductions or the introduction of the Quality Payment Program will impact overall physician reimbursement under the Medicare program. It is also unclear if changes in Medicare payments to providers would impact such providers’ willingness to prescribe and administer our products, if approved.

Reworded

Historically, allmuch of our current and near-term projected revenues have been derived from products under the GSK Agreements. We expect royalties from such products will likely continue to comprise a portion of our revenues in the future. Any action or inaction by either GSK or us that results in a material dispute, allegation of breach, litigation, arbitration, or significant disagreement between the parties may be interpreted negatively by the market or by our investors, could harm our business and cause the price of our securities to fall. Examples of these kinds of issues include but are not limited to non‑performance of contractual obligations and allegations of non‑performance, disagreements over the relative marketing and sales efforts for our partnered products and other GSK respiratory products, disputes over public statements, and similar matters.

Reworded

GSK is a strategic partner with rights and obligations under the GSK Agreements that cause its interests to differ from our interests and those of our stockholders. In particular, GSK has a substantial respiratory product portfolio in addition to the partnered products that are covered by the GSK Agreements. GSK may make respiratory product portfolio decisions or statements about its portfolio which may be, or may be perceived to be, harmful to the respiratory products partnered with us. For example, GSK could promote its non‑GSK/Innoviva respiratory products or a partnered product for which we are entitled to receive a lower percentage of royalties, delay or terminate the development or commercialization of the respiratory programs covered by the GSK Agreements, or take other actions, such as making public statements, that have a negative effect on our stock price. In this regard and by way of example, sales of Advair®, GSK’s approved medicine for both COPD and asthma, continue to be significantly greater than sales of RELVAR®/BREO® ELLIPTA®, and GSK has indicated publicly that it intends to continue commercializing Advair®. Also, given the potential future royalty payments which GSK may be obligated to pay under the GSK Agreements, GSK may seek to acquire us in order to reduce those payment obligations. The timing of when GSK may seek to acquire us could potentially be when it possesses information regarding the status of drug programs covered by the GSK Agreements that has not been publicly disclosed and is not otherwise known to us. As a result of these differing interests, GSK may take actions that it believes are in its best interest but which might not be in our best interest or the best interest of our stockholders.

Reworded

constraints on the movement of products and supplies through the supply chain, which can disrupt our ability to conduct clinical trials and develop and commercialize our products;

Removed

Under the Services Agreement with Sarissa Capital, we may rely on Sarissa Capital to assist in our strategic investing activity.

Removed

On December 11, 2020, we entered into the Services Agreement pursuant to which Sarissa Capital provides substantial assistance to us in connection with our acquisition strategy. Pursuant to the terms of the Services Agreement, and subject to the limitations set forth therein, Sarissa Capital will, among other things: (i) assist Innoviva in the development of an overall acquisition and investment process and strategy; (ii) advise Innoviva on market trends, market dynamics and merger and acquisition activity; (iii) identify potential transaction targets; (iv) assist in due diligence of transaction targets and the negotiation and execution of transactions; (v) advise on the growth and operational plans, performance and integration of target companies once an investment or acquisition is made; and (vi) assist in the identification of director and officer candidates for target companies. The services are provided by Sarissa Capital personnel and we have limited or no ability to control the manner upon which the services are provided. In the event that Sarissa Capital fails to adequately perform the required services, our investment activity operations and financial performance may be negatively impacted.

Added

The risks associated with this investment strategy may be substantially greater than the risks associated with traditional fixed-income investment strategies or other low-yield strategies.

Removed

While we expect that a portion of our revenues will continue to be derived from our royalty management business and the sales of our products, as a result of this investment, we may derive a material portion of our income from assets managed by Sarissa Capital. The investment strategy of Sarissa Capital will focus on a concentrated portfolio of “long” positions in publicly or privately traded securities (debt or equity) and derivatives of, and other financial instruments related to, each of the foregoing, specifically in the areas of healthcare, pharmaceuticals and biotechnology. The risks associated with this investment strategy may be substantially greater than the risks associated with traditional fixed-income investment strategies or other low-yield strategies.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

33new paragraphs
51removed paragraphs
31reworded paragraphs
8,439 → 7,126words in section

New heading “Capital Allocation”

Removed heading “Update on Strategic Healthcare Assets”

Removed heading “Business Combinations”

Removed heading “Revenue Recognition from Royalties”

Removed heading “Capitalized Fees Paid”

Removed heading “Factors Affecting Comparability”

Removed heading “Loss on Debt Extinguishment”

Removed heading “Gain on Sale of TRC”

Removed heading “Net Income Attributable to Noncontrolling Interest”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text
“Net Income Attributable to Noncontrolling Interest”
see in full comparison
Removed text topics: impairment
“We review our Capitalized Fees for impairment on a product‑by‑product basis for each major geographic area when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of Capitalized Fees is measured by comparing the asset’s carrying amount to the expected undiscounted future cash flows that the asset is expected to generate. …”
see in full comparison
Removed text
“Update on Strategic Healthcare Assets”
see in full comparison
Removed text
“Revenue Recognition from Royalties”
see in full comparison
Removed text topics: goodwill
“We use the acquisition method of accounting under Accounting Standards Codification (“ASC”) Topic 805, Business Combinations. Each acquired company’s operating results are included in our consolidated financial statements starting on the acquisition date. The purchase price is equivalent to the fair value of consideration transferred. Tangible and identifiable intangible assets acquired, liabilities assumed and any noncontrolling interest in the acquiree as of the acquisition date are recorded at the acquisition date fair value. …”
see in full comparison
Removed text
“Factors Affecting Comparability”
see in full comparison
Full comparison: every changed paragraph (115)

Green = added, red = removed. Unchanged paragraphs, 7 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Added

Innoviva, Inc. (and where context requires, together with its subsidiaries referred to as “Innoviva”, the “Company”, or “we” and other similar pronouns) 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 healthcare assets.

Reworded

Innoviva, Inc. (and where context requires, together with its subsidiaries referred to as “Innoviva”, the “Company”, the “Registrant” or “we” and other similar pronouns) is a 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 other healthcare assets Our royalty portfolio contains respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, “FF/VI”) and ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”), and up until July 2022, TRELEGY® ELLIPTA® (the combination FF/UMEC/VI). We sold our 15% ownership interest in Theravance Respiratory Company, LLC (“TRC”) on July 20, 2022, and are no longer entitled to receive royalties on sales of TRELEGY® ELLIPTA® products. Under the Long‑ActingLong-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® as follows: 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales above $3.0 billion; and royalties from the sales of ANORO® ELLIPTA®, which tier upward at a range from 6.5% to 10%.

Added

Our wholly owned, robust critical care and infectious disease operating platform with a hospital focus, is anchored by five differentiated approved, commercial and marketed products:

Added

GIAPREZA® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock;

Added

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter, commercially launched in 2023;

Added

XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults;

Added

ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic for the treatment of staphylococcus aureus bacteremia, including those with right-sided endocarditis, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia, licensed from Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) (“Basilea”) for U.S. commercialization and commercially launched in the third quarter of 2025; and NUZOLVENCE® (formerly known as zoliflodacin), approved by the FDA on December 12, 2025, for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents In addition, we own other strategic healthcare assets, such as a significant stake in Armata Pharmaceuticals, Inc. (“Armata”), a leader in development of bacteriophages with potential use across a range of infectious and other serious diseases. We also have economic interests in other healthcare companies through our portfolio approach.

Added

Our disciplined focus on deploying capital in areas of significant unmet medical need with high value creation potential has driven a meaningful transformation of our company over the years from a pure-play royalty business to a diversified biopharmaceutical company with a strong, fast-growing, differentiated operating platform and multiple other assets with significant promise. We believe we are well-positioned to deliver significant long-term shareholder value.

Removed

We expanded our portfolio through the acquisition of Entasis Therapeutics Holdings Inc. (“Entasis”) on July 11, 2022 and the acquisition of La Jolla Pharmaceutical Company (“La Jolla”) on August 22, 2022. Following the acquisitions, our commercial and marketed products include GIAPREZA®(angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) approved for the treatment of complicated intra-abdominal infections in adults. Our new commercial and marketed product, XACDURO® (formerly known as sulbactam-durlobactam or SUL-DUR), was approved by the United States Food and Drug Administration (“FDA”) on May 23, 2023 for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. We commenced commercial sales of XACDURO® in the third quarter of 2023. On December 14, 2024, we entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) (“Basilea”) for the commercialization of ZEVTERA®(ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. We continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S. FDA in early 2025. As such, we have a wholly owned robust critical care and infectious disease operating platform with hospital focus anchored by four differentiated products with significant growth potential and a promising drug candidate.

Removed

In addition, we own other strategic healthcare assets, such as a large equity stake in Armata Pharmaceuticals (“Armata”), a leader in development of bacteriophage with potential use across a range of infectious and other serious diseases. We also have economic interests in other healthcare companies.

Removed

Our focus on capital allocation and shareholder value maximization has led our company to a meaningful transformation over the last two years. In 2022 our financials contained royalty revenues from TRELEGY® ELLIPTA® which was divested mid-year in an economically accretive transaction. Additionally, our acquisition and integration of operating companies and advancement of our therapeutics portfolio further changed the structure of our financials compared to prior years. Through these changes, we believe we are well-positioned to create significant long-term shareholder value.

Reworded

RoyaltyTotal revenue: FourthTotal revenue for the fourth quarter 2024 gross royalty revenue from GSK2025 was $66.0 million and full year was $255.6$114.6 million, representing 25% growth compared to $69.6total revenue of $91.8 million for the fourth quarter 2024. Total revenue for the full year 2025 was $411.3 million, reflecting 15% growth compared to total revenue of 2023 and $252.7$358.7 million for the full year 2023.2024.

Added

Royalty revenue: Fourth quarter 2025 gross royalty revenue from GSK was $58.4 million and full year was $250.3 million, compared to $66.0 million for the fourth quarter 2024 and $255.6 million for the full year 2024.

Added

Net product sales: Fourth quarter 2025 net product sales were $59.1 million, more than doubling from $28.9 million in the same quarter of 2024. Full year 2025 net product sales were $172.1 million, an increase of 77% compared to $97.5 million for the full year 2024.

Added

For the fourth quarter 2025, U.S. net product sales were $33.9 million and ex-U.S. net product sales were $25.1 million. Fourth quarter 2025 U.S. net product sales primarily consisted of $19.3 million from GIAPREZA®, $10.7 million from XACDURO®, and $3.8 million from XERAVA®.

Added

For the full year 2025, U.S. net product sales were $119.2 million and ex-U.S. net product sales were $52.9 million. Full year 2025 U.S. net product sales primarily consisted of $71.8 million from GIAPREZA®, $33.4 million from XACDURO®, and $13.3 million from XERAVA®.

Added

Income from operations: Fourth quarter 2025 income from operations was $39.0 million, compared to $43.1 million for the fourth quarter 2024. Full year 2025 income from operations was $163.7 million, compared to $166.9 million for the full year 2024, reflecting continued investments in research and development.

Removed

Net Product Sales: Fourth quarter 2024 net product sales were $28.9 million, which included U.S. net product sales of $24.9 million, compared to $19.7 million for the fourth quarter of 2023, and ex-U.S. net product sales of $4.0 million. U.S. net product sales consisted of $15.9 million from GIAPREZA®, $3.1 million from XERAVA®, and $5.9 million from XACDURO®. Full year 2024 net product sales were $97.5 million, which included U.S. net product sales of $80.9 million, compared to $55.1 million for full year 2023, and ex-U.S. net product sales of $16.6 million. U.S. net product sales consisted of $53.4 million from GIAPREZA®, $12.8 million from XERAVA®, and $14.7 million from XACDURO®.

Removed

License revenue: Fourth quarter 2024 license revenue of $0.4 million included product development cost-sharing reimbursements from our partner. Full year 2024 license revenue of $19.5 million consisted of an $8.0 million milestone payment and $11.5 million cost-sharing reimbursements, compared to $11.0 million milestone payments in full year 2023.

Reworded

Equity and long-term investments: Fourth quarter and full year 20242025 net favorable changes in fair values of equity and long-term investments oftotaled $19.6$153.8 million and $123.4$161.6 million, respectively, and were primarily attributable to share price depreciationappreciation of ArmataArmata. Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $614.0 million as of December 31, 2025, and consisted of $397.9 million in Armata investments, $136.4 million in other strategic equity investments.and convertible debt investments, and $79.7 million in investments held by ISP Fund.

Reworded

Net income: Fourth quarter 20242025 net income of $20.3$164.2 million ($0.32$2.19 basic net incomeearnings per share) and full year 20242025 net income of $23.4$271.2 million ($0.37$4.02 basic net incomeearnings per share) were driven primarily by higher revenue,revenue offset byand the negativepositive impact of changes in the fair values of equity and long-term investments.

Removed

ZEVTERA® (ceftobiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (“SAB”) and endocarditis. ZEVTERA® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

Removed

In the fourth quarter of 2024, Innoviva licensed U.S. commercialization and distribution rights to ZEVTERA® from Basilea.

Removed

The Company anticipates launching ZEVTERA® in the U.S. in mid-2025.

Reworded

ZoliflodacinNUZOLVENCE® (zoliflodacin): a potential first-in-class, single dose,single-dose oral antibioticmedication isfor currentlythe beingtreatment 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”) for the treatment of patients with uncomplicated gonorrhea..

Added

In December 2025, IST received FDA approval of NUZOLVENCE® for the treatment of uncomplicated urogenital gonorrhea.

Added

FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries.

Added

Additionally, in December 2025, the positive NUZOLVENCE® Phase 3 data for the treatment of uncomplicated urogenital gonorrhea were published in The Lancet.

Added

The Company plans to commercialize NUZOLVENCE® in the second half of 2026, either in collaboration with a commercialization partner or independently.

Added

In October 2025, IST delivered data from from six presentations at IDWeek 2025, including clinical data, pharmacokinetic/pharmacodynamic analyses, and microbiologic surveillance from its growing portfolio of antibiotics and critical care medicines.

Added

Both ZEVTERA® (ceftobiprole medocaril sodium) and XACDURO® (sulbactam for injection; durlobactam for injection) were nominated for the 2025 Prix Galien USA Award for Best Pharmaceutical Product by the Galien Foundation, one of the most prestigious honors in the biopharmaceutical and medical technology fields, celebrating groundbreaking achievements that drive meaningful progress.

Added

Capital Allocation

Added

Since the inception of the share repurchase program, the Company has repurchased 797,298 shares for $16.0 million.

Added

In October 2025, Innoviva invested $17.5 million in the Series B Preferred Stock of Beacon Biosignals, Inc., an AI-driven neurotechnology company developing treatments for neurological, psychiatric, and sleep disorders.

Removed

In 2024, the Company reported positive Phase 3 data for zoliflodacin, in which a single dose of oral zoliflodacin achieved a statistically non-inferior microbiological cure rate compared to the current global standard of care. Oral zoliflodacin was generally well tolerated and emergent adverse events were comparable between treatment arms. No deaths or other serious adverse events were reported.

Removed

The Company remains on track to submit the zoliflodacin NDA to the FDA in early 2025.

Removed

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.

Removed

XACDURO® was approved in China by the National Medical Products Administration for use in Chinese patients 18 years of age and older in May 2024.

Removed

In July, XACDURO® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance.

Removed

In August, XACDURO® was nominated for the prestigious Prix Galien USA award for Best Biotechnology Product.

Removed

Update on Strategic Healthcare Assets

Removed

Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $501.5 million as of December 31, 2024. In the fourth quarter 2024, we continued to support product developments and invested $10.9 million in Gate Neurosciences, Inc., a leader in developing precision medicines targeting synaptic health.

Reworded

In November 2002, we entered into the LABA Collaboration Agreement with GSK to develop and commercialize once‑dailyonce-daily LABA products for the treatment of chronic obstructive pulmonary disorder (“COPD”) and asthma (the “LABA Collaboration Agreement”). For the treatment of COPD, the collaboration has developed threethe following combination products:

Reworded

RELVAR®//BREO® ELLIPTA® (“FF/VI”) (BREO® ELLIPTA® is the proprietary name in the U.S. and Canada and RELVAR® ELLIPTA® is the proprietary name outside the U.S. and Canada), a once‑dailyonce-daily combination medicine consisting of a LABA, vilanterol (VI), and an inhaled corticosteroid (“ICS”), fluticasone furoate (“FF”), and ANORO® ELLIPTA® (“UMEC/VI”), a once‑dailyonce-daily medicine combining a long‑actinglong-acting muscarinic antagonist (“LAMA”), umeclidinium bromide (“UMEC”), with a LABA, vilanterol (VI), and TRELEGY® ELLIPTA® (the combination FF/UMEC/VI), a once‑daily combination medicine consisting of an ICS, LAMA and LABA..

Reworded

As a result of the launch and approval of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® in the U.S., Japan and Europe, in accordance with the LABA Collaboration Agreement, we paid approval and launch milestone paymentsfees to GSK totaling $220.0 million during the year ended December 31, 2014. Although we have no further milestone payment obligations to GSK pursuant to the LABA Collaboration Agreement, we continue to have ongoing commercialization activities under the LABA Collaboration Agreement, including participation in the joint steering committee that are expected to continue over the life of the agreement. The milestone fees paid to GSK were recognized as capitalized fees, which are being amortized over their estimated useful lives commencing upon the commercial launch of the products.

Reworded

We are entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® as follows: 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales above $3.0 billion. On sales of ANORO® ELLIPTA®, royalties are upward tiering and range from 6.5% to 10%. We no longer receive royalties on sales of TRELEGY® ELLIPTA® after we sold our royalty rights along with the sale of our ownership in TRC in July 2022.

Removed

As mentioned above, on July 20, 2022, we sold our ownership interest in TRC, which received royalty payments from GSK stemming from sales of TRELEGY® ELLIPTA®. We retained our royalty rights with respect to RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®.

Reworded

On December 11, 2020, we entered into a Strategic Advisory Agreement (the “Services Agreement”) with Sarissa Capital Management LP (“Sarissa Capital”), pursuant to which Sarissa Capital provides a variety of strategic services to us in order to assist us in the development and execution of our acquisition strategy. The services are provided free of charge to us. Sarissa Capital iswas considered to be a related party dueup tountil itsthe investmentannual stockholders meeting in Innoviva’sMay common2025 stockafter andwhich itsthere representationwere no representatives of Sarissa Capital serving on our boardBoard of directors.Directors.

Reworded

On December 11, 2020, Innoviva Strategic Partners LLC (“Strategic Partners”), our wholly owned subsidiary, entered into a subscription agreement (the “Subscription Agreement”) and an Amended and Restated Limited Partnership Agreement (the “Partnership Agreement”) pursuant to which Strategic Partners became a limited partner of ISP Fund LP (the “Partnership”). The general partner of the Partnership (the “General Partner”) is an affiliate of Sarissa Capital and, pursuant to an investment management agreement, Sarissa Capital acts as the investment adviser to the Partnership. Strategic Partners made a $300.0 million initial contribution into the Partnership. The Partnership was formed for the purposes of investing in equity securities in the healthcare, pharmaceutical and biotechnology industries. The Partnership Agreement provides for Sarissa Capital to receive a customary one percent management fee from the Partnership, payable quarterly in advance, measured based on the Net Asset Value of Strategic Partners’ capital account in the Partnership. In addition, the General Partner is entitled to a customary 10% annual performance allocation based on the Net Profits of the Partnership during the annual measurement period. The Partnership Agreement includes a lock-up period of thirty-six months after which Strategic Partners is entitled to make withdrawals from the Partnership as of such lock-up expiration date and each anniversary thereafter, subject to certain limitations. In 2024, the lock-up period expired, and we elected to unwind the capital accounts in the Partnership. We expect to receive distributions through April 2026.

Removed

In May 2021, Strategic Partners received a distribution of $110.0 million from the Partnership to provide funding to Innoviva for a strategic repurchase of Innoviva common shares held by GSK. On March 30, 2022, Strategic Partners made an additional capital contribution of $110.0 million to the Partnership pursuant to the letter agreement entered into between Strategic Partners, the Partnership and Sarissa Capital Fund GP LP on May 20, 2021. The capital contribution is subject to a 36-month lock-up period from the contribution date.

Removed

The lock-up period for our initial contribution of $190.0 million expired in December 2023. Strategic Partners did not elect to make a withdrawal in 2023, thereby extending the lock-up period and withdrawal elections into subsequent years. In October 2024, we made an election to unwind the capital accounts in the Partnership in accordance with the terms of the Partnership Agreement and we expect to receive distributions of our capital accounts through April 2026.

Removed

Business Combinations

Removed

We use the acquisition method of accounting under Accounting Standards Codification (“ASC”) Topic 805, Business Combinations. Each acquired company’s operating results are included in our consolidated financial statements starting on the acquisition date. The purchase price is equivalent to the fair value of consideration transferred. Tangible and identifiable intangible assets acquired, liabilities assumed and any noncontrolling interest in the acquiree as of the acquisition date are recorded at the acquisition date fair value. Goodwill is recognized for the excess of purchase price over the net fair value of assets acquired and liabilities assumed.

Removed

Amounts allocated to assets and liabilities are based upon fair values. Such valuations require us to make significant estimates and assumptions, especially with respect to the identifiable intangible assets. We make estimates of fair value based upon assumptions believed to be reasonable and that of a market participant. Significant estimates and assumptions may involve projected future revenues, earnings, cash flows, estimated probabilities of certain milestone achievements, discount rates, asset lives, among other items. Our estimates may also impact our deferred tax assets and liabilities. Unanticipated events and circumstances may occur that may affect the accuracy and validity of such assumptions, estimates or actual results. Our estimates are based on available historical information as well as future expectations, and the estimates are inherently uncertain. The separately identifiable intangible assets generally include marketed products, in-process research and development and collaboration agreement.

Removed

Revenue Recognition from Royalties

Removed

We recognize the royalty revenue on net sales of products with respect to which we have contractual royalty rights in the period in which the royalties are earned. The net sales reports provided by our partner are based on its methodology and assumptions to estimate rebates and returns, which it monitors and adjusts regularly in light of contractual and legal obligations, historical trends, past experience and projected market conditions. Our partner may make significant adjustments to its sales based on actual results recorded, which could cause our royalty revenue to fluctuate. We conduct periodic royalty audits to evaluate the information provided by our partner. Royalties are recognized net of amortization of capitalized fees associated with any approval and launch milestone payments made to GSK.

Added

We may also enter into contracts that involve a series of manufacturing processes for products and related components. For any distinct performance obligation where the manufacturing process does not create an asset with alternative use and there is an enforceable right to payment for the performance completed to date, the related revenue is recognized over time. For these performance obligations satisfied over time, we use an input method to measure progress. Specifically, we apply the cost-to-cost method, under which progress is calculated as the ratio of costs incurred to date relative to the total estimated costs of the contract. This method most accurately depicts the transfer of value to the customer because costs incurred are determined to be proportionate to our performance in satisfying the obligation. Estimated total contract costs are reassessed periodically. Changes in estimates are accounted for prospectively as changes in estimates.

Removed

Capitalized Fees Paid

Removed

We review our Capitalized Fees for impairment on a product‑by‑product basis for each major geographic area when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of Capitalized Fees is measured by comparing the asset’s carrying amount to the expected undiscounted future cash flows that the asset is expected to generate. The determination of recoverability typically requires various estimates and assumptions, including estimating the useful life over which cash flows will occur, their amount, and the asset’s residual value, if any. We derive the required cash flow estimates from near‑term forecasted product sales and long‑term projected sales in the corresponding market. Based upon our analyses of past, current and future sales and trends, there have been no indicators of impairment and no impairment charges have been recorded on the Capitalized Fees as of December 31, 2024.

Reworded

Our investments in Armata include a convertible note (the “Armata Convertible Note”) and term loans issued in July 20232023, March 2024, March 2025 and MarchAugust 2024 (the “July 2023 Armata Term Loan ” and the “March 2024 Armata Term Loan”, respectively),2025, all of which are classified as Level 3 financial instruments. The Armata Convertible Note is measured at fair value using a Monte Carlo simulation model with the probability of certain qualified events and the assumptions of risk-free rate, volatility of stock price and timing of certain qualified events. We measure the Julyterm 2023 Armata Term Loan and the March 2024 Armata Term Loanloans at fair value using an income approach based on the discounted value of expected future cash flows.

Showing the first 60 of 115 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-05 (period ending 2026-06-30) with 10-Q filed 2026-05-06 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

0new paragraphs
0removed paragraphs
0reworded paragraphs
41 → 41words in section

The section in the latest 10-Q reads in full:

Our business is subject to a number of risks, including those identified in Item 1A of Part I of our 2025 Form 10-K. There have been no material changes to the risk factors described in our 2025 Form 10-K.

No wording changes found in this section.

Full comparison: every changed paragraph (0)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

10new paragraphs
6removed paragraphs
30reworded paragraphs
4,579 → 4,807words in section

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: russia, labor
“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.”
see in full comparison
Removed text
“The changes in fair values of other equity and long-term investments primarily reflected the realized gains and losses and net unrealized gains and losses in our strategic investments in Armata, InCarda, Syndeio, Lyndra and those investments managed by ISP Fund LP. We recorded $47.8 million net positive changes in fair values of equity and long-term investments for the three months ended March 31, 2026 related to other long-term investments we made in Armata, and net negative changes in fair value of our investments in Syndeio of $13.8 million for the three months ended March 31, 2026. …”
see in full comparison
New text
“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.”
see in full comparison
Removed text
“Net cash provided by investing activities for the three months ended March 31, 2026 of $37.0 million primarily consisted of $43.3 million in sales of equity investments managed by ISP Fund LP and $6.7 million in net purchases and sales of other investments managed by ISP Fund LP, partially offset by $10.0 million in purchases of trading securities and $2.5 million in purchases of equity investments managed by ISP Fund LP.”
see in full comparison
Reworded

Paragraph as it now reads, with added and removed wording marked:

Net cash used in investing activities for the threesix months ended MarchJune 31,30, 20252026 of $34.7$18.3 million primarily consisted of $34.7$65.0 million in purchases of trading securities and $19.9other equity investments, $3.3 million in net purchases of otherequity investments managed by ISP Fund LP.LP Theand use$0.9 million in purchases of cashproperty forand investing activities wasequipment, partially offset by proceeds of $19.9$44.1 million from thein sales of equity investments managed by ISP Fund LP, and $6.7 million in net purchases and sales of other investments managed by ISP Fund LP.
see in full comparison
Reworded

Paragraph as it now reads, with added and removed wording marked:

Net cash provided by operating activities for the threesix months ended MarchJune 31,30, 2025 was $48.6$92.7 million, consisting primarily of our net lossincome of $46.6$17.1 million, adjusted for net non-cash items, which included $78.8$54.5 million in changes in fair value of our investments, $6.5$13.0 million of amortization of acquired intangible assets, $3.5$7.0 million of amortization of capitalized fees,fees $2.1and depreciation of property and equipment, $4.6 million of stock-based compensation,compensation $0.2and $1.1 million in amortization of inventorydebt fair value step-up adjustmentsdiscount and $2.9issuance costs, partially offset by $4.7 million in net changes in operating assets and liabilities.
see in full comparison
Full comparison: every changed paragraph (46)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

FirstSecond Quarter 2026 and Recent Highlights:

Reworded

Total revenue: $98.0$119.6 million, yieldingrepresenting 11%19% year-on-year growth compared to $88.6$100.3 million for the firstsecond quarter 2025.

Reworded

Royalty revenue: gross royalty revenue from GSK wasremains $58.6stable million,at $59.8 million in the second quarter of 2026, a 2% increase compared to $61.3$58.6 million forin the first quarter 2025.of 2026.

Reworded

Net product sales: $41.4$51.8 million ($34.2$36.6 million U.S. and $7.2$15.2 million ex-US), representing 37%46% growth compared to $30.3$35.5 million in the samesecond quarter of 2025. U.S. net product sales primarily consisted of $19.7$21.0 million from GIAPREZA®, $11.6$12.0 million from XACDURO®, and $2.5$3.3 million from XERAVA®.

Reworded

Income from operations: $38.2$50.9 million, compared to $41.4$48.8 million for the firstsecond quarter 2025, reflecting continuedhigher investment in commercial activities, as well asnet product sales and businesscontinued development.operating discipline.

Reworded

Equity and long-term investments: net favorableunfavorable changes in fair value of equity and long-term investments totaled $191.2$161.0 million, primarily attributable to a lower share price appreciation of Armata.Armata . Innoviva’s strategic healthcare investments were valued at $773.3$669.5 million as of MarchJune 31,30, 2026, and consisted of $603.4$457.7 million in Armata, $138.2$177.3 million in other strategic equity and convertible debt, and $31.7$34.5 million held by ISP Fund.

Reworded

Net income: $186.6net millionloss ($2.52of $83.4 million, or $1.14 basic earningsloss per share) wasshare, driven primarily by higher revenue and the positive impact of changesdecrease in the fair valuesvalue of equity and long-term investments.

Reworded

Cash and cash equivalents: totaledTotaled $603.1$570.4 million. Royalty and net product sales receivables totaled $92.6$110.6 million as of MarchJune 31,30, 2026.2026, a 25% year-on-year increase compared to $88.3 million for the second quarter of 2025.

Added

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.

Added

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.

Removed

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").

Removed

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

Removed

The Company remains on track to make NUZOLVENCE® available to patients in the second half of 2026.

Added

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.

Added

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.

Removed

Innoviva’s strategic healthcare asset portfolio experienced meaningful growth this quarter, including notable value crystallization at Armata. 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.

Reworded

During the firstsecond quarter of 2026, Innoviva repurchased 971,0661,403,247 shares for $20.4$31.4 million under its $125 million share repurchase program. Since its inception, and through the end of thisthe second quarter, the Company has repurchased 1,198,9212,602,168 shares for $25.0$56.4 million, reflecting the Company’s continued confidence in its intrinsic value and long-term outlook.

Added

During the second quarter of 2026, Innoviva continued to support companies in its strategic healthcare asset portfolio with $55.0 million aggregate capital commitment.

Reworded

Total net royalty revenue decreased to $55.2$56.3 million and $111.5 million for the three and six months ended MarchJune 31,30, 2026, compared to $57.8$63.9 million and $121.7 million for the same periodperiods a year ago. The decrease in total net royalty revenue was primarily due to lower net sales driven by pricing pressures in the United States.

Reworded

Our net product sales increased overall during the periods presented, driven by higher sales volume resulting from our strategic commercialization efforts and dedication to delivering our critical care products to healthcare systems. The increase in XACDURO® ex-U.S. product sales is attributable mainly to product sales under an interim supply agreement with Zai Lab, which is billed at cost.

Reworded

License and other revenue for the three and six months ended MarchJune 31,30, 2026 was derived primarily from our ongoing arrangements with Zai Lab and new agreements with GARDP and DRL as discussed in Note 4, “License, Collaboration and Other Arrangements”, to the Condensed Consolidated Financial Statements.

Reworded

The cost of products sold also includes the inventory step-up value from the acquisition of La Jolla, which is recorded upon the sale of such inventory. The step-up value included above amounted to $1.1$0.9 million and $0.2$2.0 million for the three and six months ended MarchJune 31,30, 20262026, respectively, and $0.4 million and $0.6 million for the three and six months ended June 30, 2025, respectively. Our cost of products sold increased during the three and six months ended MarchJune 31,30, 2026, driven by higher product sales volume. As of MarchJune 31,30, 2026, our total inventory included the remaining net fair value adjustments resulting from the acquisition of La Jolla of approximately $2.2$1.4 million, which will be recognized as cost of products sold when sales occur in future periods.

Reworded

Research and development expenses for the three and six months ended MarchJune 31,30, 2026 were $5.2 million.million and $10.4 million, respectively. The expenses for the current period include additional personnel and facilities costs in support of the acquired IPR&D as discussed in Note 13, “Asset Acquisition”, in the Condensed Consolidated Financial Statements. Research and development expenses for the three and six months ended MarchJune 31,30, 2025, which wereconsisted mainlyprimarily attributableof tothe post-marketingcontinued commitmentsadvancement requiredof zoliflodacin, approved by the FDA andin ongoingDecember product developments,2025, were $4.4$8.0 million.million and $12.4 million, respectively.

Reworded

Our selling, general and administrative expenses were $32.4 million and $27.5 millionincreased for the three and six months ended MarchJune 31,30, 20262026, andcompared 2025,to respectively.the corresponding periods in 2025. The increase during the current period iswas aprimarily resultattributable ofto our ongoing efforts to expand our sales force to meet demand in new regions, promote our marketed critical care products and drive revenue, maintain regulatory compliance, and support essential administrative functions for general operations.

Reworded

Interest and dividend income increased for the three and six months ended MarchJune 31,30, 2026, compared to the same period in 2025, due to higher average balances of our cash equivalents, money market funds and other interest-bearing investments.

Reworded

Our interest expense for the three and six months ended MarchJune 31,30, 2026 and 2025 comprised mainly of the contractual interest expense and the amortization of debt issuance costs for our 2028 Notes, as well as effective interest expense on our deferred royalty obligation related to GIAPREZA®. The increase for the three and six months ended MarchJune 31,30, 2026, compared to the same period in 2025, was mainly due to higher interest expense on our deferred royalty obligation as a result of higher sales performance of GIAPREZA®.

Reworded

The changes in fair values of equity method investments for the three and six months ended MarchJune 31,30, 2026 were favorabledriven mainlyby due to the appreciationfluctuations in Armata’s stock price.price during the reporting periods. We recorded $157.7$131.8 million in unrealized loss and $25.8 million in unrealized gain for the three and six months ended MarchJune 31,30, 2026, respectively, compared to $13.5$13.1 million in unrealized gain and $0.5 million in unrealized loss for the three and six months ended MarchJune 31,30, 2025.2025, respectively.

Added

The changes in fair values of other equity and long-term investments primarily reflected the net realized gains and losses and net unrealized gains and losses in our strategic investments in Armata, Syndeio, Lyndra and those investments managed by ISP Fund LP.

Added

We recorded $38.8 million in net negative changes in fair values of equity and long-term investments for the three months ended June 30, 2026 and $8.9 million in net positive changes in fair values of equity and long-term investments for the six months ended June 30, 2026, respectively, related to other long-term investments we made in Armata.

Added

We recorded net positive changes in fair value of our investments in Syndeio of $6.6 million and net negative changes of $7.2 million for the three and six months ended June 30, 2026, respectively.

Added

We recorded $3.0 million and $2.7 million in net positive changes in fair values of equity and long-term investments related to the investments managed by ISP Fund LP for the three and six months ended June 30, 2026, respectively.

Removed

The changes in fair values of other equity and long-term investments primarily reflected the realized gains and losses and net unrealized gains and losses in our strategic investments in Armata, InCarda, Syndeio, Lyndra and those investments managed by ISP Fund LP. We recorded $47.8 million net positive changes in fair values of equity and long-term investments for the three months ended March 31, 2026 related to other long-term investments we made in Armata, and net negative changes in fair value of our investments in Syndeio of $13.8 million for the three months ended March 31, 2026. We recorded $83.7 million of net negative changes in fair values of equity and long-term investments related to the investments managed by ISP Fund LP for the three months ended March 31, 2025. We also recorded $3.3 million net negative changes in fair values of equity and long-term investments for the three months ended March 31, 2025 related to other long-term investments we made in Armata. These net negative changes in fair values were partially offset by a favorable net change in fair value of our investments in Syndeio of $19.3 million.

Reworded

We recorded income tax benefit of $24.6 million and income tax expense of $48.0$23.4 million for the three and six months ended MarchJune 31,30, 2026, respectively, compared to income tax expense of $8.0$8.9 million and $16.9 million for the three and six months ended MarchJune 31,30, 2025.2025, respectively. The effective income tax rate for the threesix months ended MarchJune 31,30, 2026 and 2025 was 20.5%18.5% and (20.7)%,49.7%, respectively.

Reworded

Since our inception, we have financed our operations primarily through private placements and public offerings of equity and debt securities and payments received under collaborative arrangements. For the threesix months ended MarchJune 31,30, 2026, we generated gross royalty revenues from GSK of $58.6$118.4 million, net product sales of $41.4$93.1 million and license and other revenue of $1.5$12.9 million. Cash and cash equivalents totaled $603.1$570.4 million, royalties receivable from GSK totaled $58.6$59.8 million and accounts receivable associated with our product sales and license and other revenue totaled $34.0$50.8 million as of MarchJune 31,30, 2026.

Reworded

As of MarchJune 31,30, 2026, we had one outstanding convertible note, the 2028 Notes, in an aggregate principal amount of $261.0 million, which will become due in March 2028. Future interest payments associated with this note total $13.9 million.

Reworded

On November 3, 2025, our Board of Directors authorized a share repurchase program under which we may repurchase up to $125.0 million of Innoviva’s outstanding shares of common stock. From program inception through MarchJune 31,30, 2026, we have repurchased Innoviva common stock in the open market for total price of approximately $25.0$56.4 million. This program has no termination date, may be suspended or discontinued at any time at our discretion and does not oblige us to acquire any amount of common stock.

Reworded

We believe that our cash and cash equivalents will be sufficient to meet our anticipated debt service and operating needs, as well as our ongoing share repurchase program, for at least the next 12 months based upon current operating plans and financial forecasts. Our long-term capital requirements will depend on many factors including the amount of our royalty revenues, sales growth of our currently marketed products, timing of regulatory approval of our product candidates and outcome of our acquisitions and strategic investments. If our current operating plans and financial forecasts change, we may require additional funding sooner in the form of public or private equity offerings or debt financings. Furthermore, if in our view favorable financing opportunities arise, we may seek additional funding in the form of public or private equity offerings or debt financings at any time. However, future financing may not be available in amounts or on terms acceptable to us, if at all. This could leave us without adequate financial resources to fund our operations as currently planned. In addition, from time to time we may restructure or reduce our debt, including through privately negotiated repurchases, tender offers, redemptions, amendments, or otherwise, all allowable with the terms of our debt agreements.

Reworded

Net cash provided by operating activities for the threesix months ended MarchJune 31,30, 2026 was $35.3$87.3 million, consisting primarily of our net income of $186.6$103.2 million, adjusted for net non-cash items, which included $41.0$4.9 million of deferred income taxes, $6.6$13.2 million of amortization of acquired intangible assets, $3.5$7.0 million of amortization of capitalized fees and depreciation of property and equipment, $2.6$7.3 million of stock-based compensation and $1.1$2.0 million of inventory fair value step-up adjustments, offset by $191.2$30.2 million in net changes in fair value of our investments and $16.3$22.1 million in net changes in operating assets and liabilities.

Reworded

Net cash provided by operating activities for the threesix months ended MarchJune 31,30, 2025 was $48.6$92.7 million, consisting primarily of our net lossincome of $46.6$17.1 million, adjusted for net non-cash items, which included $78.8$54.5 million in changes in fair value of our investments, $6.5$13.0 million of amortization of acquired intangible assets, $3.5$7.0 million of amortization of capitalized fees,fees $2.1and depreciation of property and equipment, $4.6 million of stock-based compensation,compensation $0.2and $1.1 million in amortization of inventorydebt fair value step-up adjustmentsdiscount and $2.9issuance costs, partially offset by $4.7 million in net changes in operating assets and liabilities.

Removed

Net cash provided by investing activities for the three months ended March 31, 2026 of $37.0 million primarily consisted of $43.3 million in sales of equity investments managed by ISP Fund LP and $6.7 million in net purchases and sales of other investments managed by ISP Fund LP, partially offset by $10.0 million in purchases of trading securities and $2.5 million in purchases of equity investments managed by ISP Fund LP.

Reworded

Net cash used in investing activities for the threesix months ended MarchJune 31,30, 20252026 of $34.7$18.3 million primarily consisted of $34.7$65.0 million in purchases of trading securities and $19.9other equity investments, $3.3 million in net purchases of otherequity investments managed by ISP Fund LP.LP Theand use$0.9 million in purchases of cashproperty forand investing activities wasequipment, partially offset by proceeds of $19.9$44.1 million from thein sales of equity investments managed by ISP Fund LP, and $6.7 million in net purchases and sales of other investments managed by ISP Fund LP.

Added

Net cash used in investing activities for the six months ended June 30, 2025 of $1.6 million primarily consisted of $34.7 million in purchases of trading securities, partially offset by $28.0 million in sales of equity investments and net purchases and sales of other investments managed by ISP Fund LP and $5.1 million in proceeds from trading securities.

Reworded

Net cash used in financing activities for the threesix months ended MarchJune 31,30, 2026 of $20.1$49.6 million was primarily due to $20.2$51.3 million in repurchases of our common stock under the ongoing stock repurchase program.program, partially offset by net proceeds of $2.0 million from issuances of common stock.

Reworded

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 of $0.2$1.4 million was primarily due to net proceeds from issuances of common stock, partially offset by the repurchase of shares to satisfy tax withholding.

Reworded

As of MarchJune 31,30, 2026, our notes payable obligation comprised of $261.0 million related to our 2028 Notes, which are due in 2028. Under the terms of the 2028 Notes, we make interest payments of 2.125% of outstanding principal. Refer to Note 11, “Debt” to the Condensed Consolidated Financial Statements for more information.

Reworded

We also entered into a Commercial Supply Agreement with Corden Pharma CHENÔVE SAS (“Corden”), under which we engaged Corden to manufacture and supply certain products related to XACDURO® and to perform certain services and studies. Under the agreement, we committed to minimum purchases through December 31, 2027. As of MarchJune 31,30, 2026, we have approximately $13.0$10.3 million U.S. dollar equivalent in outstanding purchase commitments under the agreement.

INVA insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-08-20Zhen Marianne
Chief Accounting Officer
Shares withheld for tax 1,127$21.00 $23.7K56,389 SEC
2026-08-20Basso Stephen
Chief Financial Officer
Shares withheld for tax 558$21.00 $11.7K88,013 SEC
2026-08-20Raifeld Pavel
Director, Chief Executive Officer
Shares withheld for tax 1,130$21.00 $23.7K284,799 SEC
2026-05-20Basso Stephen
Chief Financial Officer
Shares withheld for tax 559$22.24 $12.4K88,571 SEC
2026-05-20Raifeld Pavel
Director, Chief Executive Officer
Shares withheld for tax 1,130$22.24 $25.1K285,929 SEC
2026-05-20Zhen Marianne
Chief Accounting Officer
Shares withheld for tax 1,127$22.24 $25.1K57,516 SEC
2026-05-18Linden Josephine
Director
Grant/award 5,733— —5,733 SEC
2026-05-18Linden Josephine
Director
Grant/award 9,461— —15,194 SEC
2026-05-15Basso Stephen
Chief Financial Officer
Grant/award 1,123— —89,130 SEC
2026-05-15Raifeld Pavel
Director, Chief Executive Officer
Grant/award 1,123— —287,059 SEC
2026-05-04Dipaolo Mark
Director
Grant/award 9,786— —140,492 SEC
2026-05-04Raifeld Pavel
Director, Chief Executive Officer
Grant/award 126,646— —285,936 SEC
2026-05-04Zhen Marianne
Chief Accounting Officer
Grant/award 12,766— —58,643 SEC
2026-05-04Schlesinger Sarah J.
Director
Grant/award 9,786— —140,492 SEC
2026-05-04Basso Stephen
Chief Financial Officer
Grant/award 37,994— —88,007 SEC
2026-05-04Small Derek A
Director
Grant/award 9,786— —45,035 SEC
2026-05-04Haimovitz Jules
Director
Grant/award 9,786— —152,692 SEC

Well-known investors holding INVA (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Renaissance Technologies COM2026-06-304,036,532$91.7M0.13%No change
Millennium Management (Israel Englander) COM2026-06-302,541,109$57.7M0.04%Added 11%
Citadel Advisors (Ken Griffin) NOTE 2.125% 3/12026-06-300$38.7M0.02%No change
Point72 Asset Management (Steve Cohen) NOTE 2.125% 3/12026-06-300$25.9M0.04%No change
Two Sigma Investments COM2026-06-301,032,807$23.5M0.02%Reduced 30%
Two Sigma Investments NOTE 2.125% 3/12026-06-300$14.0M—Sold out
AQR Capital Management (Cliff Asness) COM2026-06-30549,553$12.5M0.0%Added 11%
Citadel Advisors (Ken Griffin) COM2026-06-30185,750$4.2M0.0%Added 5%
D. E. Shaw & Co. COM2026-06-30166,255$3.8M0.0%Reduced 33%
Gotham Asset Management (Joel Greenblatt) COM2026-06-3078,386$1.8M0.0%Reduced 36%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when INVA files, watchlists and downloadable comparisons.