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Item 1. Business

2026-02-25 compared with 2025-02-26 · 213 added, 205 removed, 639 unchanged (40% of the section changed)

Innoviva, Inc.

(“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.

(“Innoviva”, the “Company”, the “Registrant” 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.

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”).

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and royalties from the sales of ANORO ® ELLIPTA ® , which tier upward at a range from 6.5% to 10%.

Our commercial and marketed products include GIAPREZA ® (angiotensin II), approved in the United States (“U.S.”) to increase blood pressure in adults with septic or other distributive shock, and XERAVA ® (eravacycline) approved in the U.S.

for the treatment of complicated intra-abdominal infections in adults.

On May 23, 2023, XACDURO ® (formerly known as sulbactam-durlobactam or SUL-DUR), was approved by the United States Food and Drug Administration (“FDA”) and 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 our efforts to submit a New Drug Application (“NDA”) for zoliflodacin, a potential first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S.

FDA in early 2025.

Overall, we have a wholly owned robust critical care and infectious disease operating platform with a hospital focus anchored by four differentiated products with significant growth potential and a promising drug candidate.

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:

• 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 hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter , commercially launched in 2023 ;

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

• 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;

• 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., 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.

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, Entasis Therapeutics Holding Inc.

(“Entasis”) and La Jolla Pharmaceutical Company (“La Jolla”), 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.

We also have economic interests in other healthcare companies through our portfolio approach.

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.

Our headquarters are located at 1350 Old Bayshore Highway, Suite 400, Burlingame, CA 94010.

The Company was incorporated in Delaware in November 1996 under the name Advanced Medicine, Inc., and began operations in May 1997.

It later changed its name to Theravance, Inc.

in April 2002, and rebranded, changing its name to Innoviva, Inc.

The Company was incorporated in Delaware in November 1996 and commenced operations in May 1997 under Advanced Medicine, Inc.

The Company changed its name to Theravance, Inc.

in April 2002 and to Innoviva, Inc.

in January 2016.

Our corporate strategy is currently focused on increasing stockholder value by, among other things, maximizing the potential value of our respiratory assets partnered with GSK, creating value through our critical care and infectious disease platform, optimizing our operations, and augmenting capital allocation.

We continue to diversify our royalty management business through actively pursuing opportunistic acquisitions of promising companies and assets in the healthcare industry and enhancing the returns on our capital.

Our corporate strategy is currently focused on increasing shareholder value by, among other things, maximizing the potential value of our respiratory assets partnered with GSK, growing our critical care and infectious disease platform, efficiently allocating capital, and optimizing our operations.

We continue to diversify our royalty management business by actively pursuing opportunistic investments in, and acquisitions of, promising assets in the healthcare industry to enhance the returns on our capital.

Our Royalty Product Portfolio

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All of these efforts represent potential competition for any of our partnered products.

Efforts have intensified following the publication of FDA draft guidance for the approval of fully substitutable versions of Advair and Symbicort in late 2013 and mid-2015, respectively.

In general, these manufacturers are required to conduct a number of clinical efficacy, pharmacokinetic and device studies to demonstrate equivalence to branded products already approved by the FDA.

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Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product and products that may compete with such branded product is typically lost to the generic product.

In addition, in April 2016, the FDA issued a draft guidance document covering Fluticasone Furoate/Vilanterol Trifenatate (FF/VI), the active ingredients used in RELVAR ® /BREO ® ELLIPTA ® .

In April 2016, the FDA issued a draft guidance document covering Fluticasone Furoate/Vilanterole Trinenatate (FF/VI), the active ingredients used in RELVAR ® /BREO ® ELLIPTA ® .

In March 2020, the FDA issued a draft guidance on Umeclidinium Bromide/Vilanterol Trifenatate (UMEC/VI), the active ingredients used in ANORO ® ELLIPTA ® .

Our Integrated Critical Care / Infectious Disease Assets

Commercial and Marketed Products

Our critical care and infectious disease portfolio was formed through the 2022 acquisitions of Entasis and La Jolla, which we have continued to grow through our license agreement with Basilea.

It comprises four differentiated commercial stage products and a pipeline.

The following table summarizes our commercial and marketed products:

Our critical care and infectious disease portfolio was formed through the 2022 acquisitions of Entasis Therapeutics and La Jolla Pharmaceutical, and we have continued to grow it through our license agreement with Basilea.

The portfolio comprises five differentiated commercial stage products.

The following table summarizes our marketed products:

Pivotal Studies (1)

Regulatory Status

GIAPREZA ® (angiotensin II)

Septic or other distributive shock (2)

321-patient, multinational, double-blind, randomized, placebo-controlled study

FDA approval Dec 2017

European Commission approval Aug 2019

UK authorization (post-Brexit) Jan 2021

XACDURO ® (sulbactam for injection;

durlobactam for injection), co-packaged for intravenous use

HABP/VABP caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (6)

177-patient, active-controlled, investigator-unblinded, independent assessor-blinded, non-inferiority, phase 3 trial

FDA approval May 2023

China approval May 2024

XERAVA ® (eravacycline)

Complicated intra-abdominal infections (3, 4, 5)

446-patient, multi-national, double-blind, randomized, active-controlled study

400-patient, multi-national, double-blind, randomized, active-controlled study

FDA approval Aug 2018

European Commission approval Sep 2018

Singapore approval Apr 2020

UK authorization (post-Brexit) Jan 2021

China approval Mar 2022

Hong Kong approval Aug 2022

Taiwan approval Sept 2023

ZEVTERA ® (ceftobiprole)

Staphylococcus aureus bloodstream infection, acute bacterial skin and skin structure infections, community-acquired pneumonia (8, 9)

390-patient randomized, controlled, double-blind, multinational, multicenter trial

679-patient randomized, controlled, double-blind, multinational, multicenter trial

638-patient randomized, controlled, double-blind, multinational, multicenter study

FDA approval April 2024

NUZOLVENCE ® (zoliflodacin)

Uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae (7)

930-patient randomized, controlled, open-label, multinational, non-inferiority phase 3 trial

FDA approval Dec 2025

and European approval.

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XACDURO is a co-packaged product containing sulbactam, a beta-lactam antibacterial and beta lactamase inhibitor, and durlobactam, a beta lactamase inhibitor, indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.

ZEVTERA is a cephalosporin antibacterial indicated for the treatment of:

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(2) Including arterial and venous thrombotic events

XERAVA ® (eravacycline)

XERAVA ® (eravacycline) for injection is approved by the U.S.

FDA and Singapore Health Sciences Authority (“HSA”) as a tetracycline class antibacterial indicated for the treatment of cIAI due to susceptible microorganisms in patients 18 years of age and older.

XERAVA is approved by the EC, MHRA, and the Hong Kong Department of Health (“DoH”) for the treatment of cIAI in adults.

XERAVA is marketed in the U.S.

by our wholly owned subsidiary, Tetraphase Pharmaceuticals, Inc.

(“Tetraphase”), and is marketed in Europe and Great Britain by PAION on behalf of Tetraphase and is marketed in mainland China, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines by Everest Medicines Limited (“Everest”).

cIAIs are the second most common source of severe sepsis in the ICU cIAIs are defined as consequences of perforations of the gastrointestinal tract that result in contamination of the peritoneal space.

In July 2024, XERAVA ® was named as a recommended agent for empiric therapy in the updated 2024 SIS treatment guidelines for the management of complicated intra-abdominal infections.

SIS also recommended XERAVA ® be reserved for high-risk patients.

Investigating Gram-negative Infections Treated with Eravacycline (“IGNITE”)

XERAVA was approved by the U.S.

FDA, HSA, EC, MHRA, and DoH based on the results of IGNITE1 and IGNITE4, which were published in JAMA Surgery in March 2017 and Clinical Infectious Diseases in December 2018, respectively.

IGNITE1 was a multinational, randomized, double-blind, active-controlled study in 538 patients with clinical evidence of cIAIs requiring urgent surgical or percutaneous intervention who received either XERAVA or ertapenem.

The primary endpoint was clinical cure, defined as complete resolution or significant improvement of signs or symptoms of the index infection, at the test of cure (“TOC”) visit.

The TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered.

IGNITE4 was a multinational, randomized, double-blind, active controlled study in 499 patients with clinical evidence of cIAIs requiring urgent surgical or percutaneous intervention who received either XERAVA or meropenem.

The primary endpoint was clinical cure, defined as complete resolution or significant improvement of signs or symptoms of the index infection, at the TOC visit.

The TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered.

IGNITE1 and IGNITE4 Study Design

(1) Solomkin et al, JAMA Surgery 2017;

152(3):224-232

(2) Solomkin et al, Clinical Infectious Diseases 2018;

(3) TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered

XERAVA demonstrated statistical noninferiority in clinical cure rate in the micro-ITT population, which included all randomized subjects who had baseline bacterial pathogens that caused cIAIs and against at least one of which the investigational drug has in vitro (in a test tube) antibacterial activity (N=846).

IGNITE1 and IGNITE4 Primary Endpoint Results (1)

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Noninferiority margins of 10% and 12.5% were used for IGNITE1 and IGNITE4, respectively

Clinical cure rates across patients with gram-negative, gram-positive and anaerobic pathogens, including those with resistant strains, are shown in the following tables.

Clinical Cure Rates at TOC by Selected Baseline Pathogens in the Micro-ITT Population (1)

N=Number of subjects in the micro-ITT Population;

N1=Number of subjects with a specific pathogen;

n=Number of subjects with a clinical cure at the TOC visit

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Comparators included ertapenem and meropenem for IGNITE1 and IGNITE4, respectively

(3) Includes Streptococcus anginosus, Streptococcus constellatus, and Streptococcus intermedius

(4) Includes Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Parabacteroides distasonis

The most common adverse reactions that were reported in XERAVA-treated patients in IGNITE1 and IGNITE4 were infusion site reactions.

Selected Adverse Reactions Reported in ≥1% of Patients Receiving XERAVA (1)

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Comparators included ertapenem and meropenem for IGNITE1 and IGNITE4, respectively

(3) Infusion site reactions include:

catheter/vessel puncture site pain, infusion site extravasation, infusion site hypoaesthesia, infusion/injection site phlebitis, infusion site thrombosis, injection site/vessel puncture site erythema, phlebitis, phlebitis superficial, thrombophlebitis, and vessel puncture site swelling

XACDURO ® (sulbactam for injection;

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2023 May 11:S1473-3099(23)00184-6

XERAVA ® (eravacycline)

XERAVA ® (eravacycline) for injection is approved by the U.S.

XERAVA ® is approved by the EC, MHRA, and the Hong Kong Department of Health (“DoH”) for the treatment of cIAI in adults.

XERAVA ® is marketed in the U.S.

by our wholly owned subsidiary, Tetraphase Pharmaceuticals, Inc.

cIAIs are the second most common source of severe sepsis in the ICU.

cIAIs are defined as consequences of perforations of the gastrointestinal tract that result in contamination of the peritoneal space.

In July 2024, XERAVA ® was named as a recommended agent for empiric therapy in the updated 2024 SIS treatment guidelines for the management of complicated intra-abdominal infections.

SIS also recommended XERAVA ® be reserved for high-risk patients.

Investigating Gram-negative Infections Treated with Eravacycline (“IGNITE”)

XERAVA ® was approved by the U.S.

FDA, HSA, EC, MHRA, and DoH based on the results of IGNITE1 and IGNITE4, which were published in JAMA Surgery in March 2017 and Clinical Infectious Diseases in December 2018, respectively.

The primary endpoint was clinical cure, defined as complete resolution or significant improvement of signs or symptoms of the index infection, at the test of cure (“TOC”) visit.

The TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered.

The primary endpoint was clinical cure, defined as complete resolution or significant improvement of signs or symptoms of the index infection, at the TOC visit.

The TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered.

IGNITE1 and IGNITE4 Study Design

(1) Solomkin et al, JAMA Surgery 2017;

152(3):224-232

(2) Solomkin et al, Clinical Infectious Diseases 2018;

(3) TOC visit was conducted 25 to 31 calendar days after the first dose of the study drug was administered

XERAVA ® demonstrated statistical noninferiority in clinical cure rate in the micro-ITT population, which included all randomized subjects who had baseline bacterial pathogens that caused cIAIs and against at least one of which the investigational drug has in vitro (in a test tube) antibacterial activity (N=846).

IGNITE1 and IGNITE4 Primary Endpoint Results (1)

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Noninferiority margins of 10% and 12.5% were used for IGNITE1 and IGNITE4, respectively

Clinical cure rates across patients with gram-negative, gram-positive and anaerobic pathogens, including those with resistant strains, are shown in the following tables.

Clinical Cure Rates at TOC by Selected Baseline Pathogens in the Micro-ITT Population (1)

N=Number of subjects in the micro-ITT Population;

N1=Number of subjects with a specific pathogen;

n=Number of subjects with a clinical cure at the TOC visit

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Comparators included ertapenem and meropenem for IGNITE1 and IGNITE4, respectively

(3) Includes Streptococcus anginosus, Streptococcus constellatus, and Streptococcus intermedius

The most common adverse reactions that were reported in XERAVA ® -treated patients in IGNITE1 and IGNITE4 were infusion site reactions.

Selected Adverse Reactions Reported in ≥1% of Patients Receiving XERAVA ® (1)

(1) Charts, graphs and tables derived from FDA prescribing information

(2) Comparators included ertapenem and meropenem for IGNITE1 and IGNITE4, respectively

(3) Infusion site reactions include:

ZEVTERA ® (ceftobiprole) was approved by the U.S.

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if certain targets are met.

We anticipate commercializing ZEVTERA ® in mid-year 2025.

We commercially launched ZEVTERA ® in the U.S.

in the third quarter of 2025.

The efficacy of ZEVTERA ® in the treatment of adult patients with SAB, including right-sided infective endocarditis, was demonstrated in a randomized, controlled, double-blind, multinational, multicenter trial (NCT03138733).

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The results for clinical cure at the test-of-cure visit at Day 7 to 14 after end of treatment are shown below:

GIAPREZA ® competes with catecholamines (primarily norepinephrine), which are available as generics and inexpensive and typically used first line to treat distributive shock, and vasopressin, including Vasostrict ® (Endo International plc) and vasopressin generic drugs, which are typically used hsecond line.

In the randomized, Phase 3 study ATHOS-3, GIAPREZA ® demonstrated clinical benefit in patients who were not adequately responding to available vasopressors, including catecholamines and vasopressin.

GIAPREZA ® ’s principal competition as a treatment in patients not adequately responding to available vasopressors is the use of these same vasopressors at increased doses.

If we are unable to successfully change treatment practices, the commercial prospects for GIAPREZA ® will be limited, and our business may suffer.

XERAVA ® competes with a number of antibiotics that are currently marketed for the treatment of cIAI and other multidrug resistant infections, including:

AVYCAZ (ceftazidime and avibactam, marketed by AbbVie Inc.);

MERREM IV ® (meropenem, marketed by AstraZeneca PLC);

PRIMAXIN ® (imipenem and cilastatin, marketed by Merck & Co., Inc.);

RECARBRIO (imipenem, cilastatin, and relebactam, marketed by Merck & Co., Inc.);

TYGACIL ® (tigecycline, marketed by Pfizer Inc.);

VABOMERE (meropenem and vaborbactam, marketed by Melinta Therapeutics, Inc.);

ZERBAXA ® (ceftolozane and tazobactam, marketed by Merck & Co., Inc.);

ZOSYN ® (piperacillin and tazobactam, marketed by Pfizer Inc.);

and current and future generic versions of marketed antibiotics.

If we are unable to successfully change treatment practices, the commercial prospects for XERAVA ® will be limited, and our business may suffer.

XACDURO ® competes with a number of antibiotics that are used to treat carbapenem-resistant Acinetobacter infections in the absence of other products indicated for these infections, including:

FETROJA ® (cefiderocol, marketed by Shionogi & Co., Ltd.), UNASYN ® (ampicillin and sulbactam, marketed by Pfizer Inc.), colistin (polymyxin E), and other current and future generic versions of marketed antibiotics.

There are at least two additional early-stage clinical programs developing investigational therapies for multidrug-resistant Acinetobacter infections.

If we are unable to successfully change treatment practices, the commercial prospects for XACDURO ® will be limited, and our business may suffer.

ZEVTERA ® competes with a wide range of generic and branded antibiotics that are used to treat the various infection types for which it is indicated, including:

vancomycin, daptomycin, TEFLARO ® (ceftaroline, marketed by Allergan Sales, LLC).

If we are unable to successfully change treatment practices, the commercial prospects for ZEVTERA ® will be limited, and our business may suffer.

Regulatory Exclusivity

GIAPREZA ® , XERAVA ® and XACDURO ® are New Chemical Entities (“NCEs”) approved by the U.S.

In the U.S., NCEs approved by the FDA are eligible for market exclusivity under the U.S.

Federal Food, Drug, and Cosmetic Act (“FDCA”), which can prevent the approval of generic versions of the NCE for 5 to 7.5 years from the date of the initial approval of the NCE.

Specifically, the FDCA provides a 5-year period of marketing exclusivity within the U.S.

to the applicant that gains approval of an NDA for an NCE.

A drug is an NCE if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

During the exclusivity period, the FDA may not accept for review an Abbreviated New Drug Application (“ANDA”) or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all of the data required for approval.

However, an application may be submitted 4 years after the NDA approval of the NCE if it contains a certification of patent invalidity or non-infringement.

Should the NDA holder commence litigation against the ANDA filer within 45 days of receipt of the certification notice, an automatic stay of the approval of any generic competition goes into effect until the earlier of:

(i) 30 months from the receipt of the certification;

or (ii) a court ruling of patent invalidity or non-infringement for the relevant patents.

In the absence of a court ruling, the 30-month stay will be extended by such amount of time (if any) that is required for 7.5 years to have elapsed from the date of NDA approval of the NCE.

ZEVTERA ® was provided ten years of market exclusivity by the FDA from the date of its approval in April 2024.

On February 15, 2022, La Jolla received a paragraph IV notice of certification (the “Notice Letter”) from Gland Pharma Limited (“Gland”) advising that Gland had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of GIAPREZA ® in the U.S.

prior to the expiration of U.S.

and 11,219,662 (the “GIAPREZA ® Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).

The Notice Letter alleges that the GIAPREZA ® Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Gland’s ANDA.

On March 29, 2022, La Jolla filed a complaint for patent infringement of the GIAPREZA ® Patents against Gland and certain related entities in the United States District Court for the District of New Jersey in response to Gland’s ANDA filing.

In accordance with the Hatch-Waxman Act, because GIAPREZA ® is a new chemical entity and La Jolla filed a complaint for patent infringement within 45 days of receipt of the Notice Letter, the FDA cannot approve Gland’s ANDA any earlier than 7.5 years from the approval of the GIAPREZA ® NDA unless the District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable and/or not infringed.

On February 22, 2023, La Jolla received a paragraph IV notice of certification (the “Second Notice Letter”) from Gland advising that Gland had amended its ANDA filing to include a paragraph IV certification alleging that all claims of the newly-issued and Orange Book-listed U.S.

11,559,559 (“the ’559 Patent”), which covers GIAPREZA ® , are invalid, unenforceable and/or not infringed.

On March 22, 2023, La Jolla filed a First Amended Complaint in this litigation adding Gland’s marketing and distribution partners for its ANDA angiotensin II product, Fresenius Kabi USA LLC and Fresenius Kabi SwissBiosim GmbH (collectively, the “Fresenius Kabi Defendants”), as co-defendants.

On April 7, 2023, La Jolla filed a Second Amended Complaint in response to the Second Notice Letter, adding claims that the manufacture, use, sale, offer for sale, or import of Gland’s ANDA angiotensin II product will infringe the ’559 Patent.

On November 14, 2023, La Jolla filed a Third Amended Complaint adding additional infringement claims against the Fresenius Kabi Defendants.

On February 18, 2025, La Jolla, as well as The George Washington University (collectively, with the La Jolla entities, the “Plaintiffs”) entered into a settlement agreement (the “Settlement Agreement”) with Gland and the Fresenius Kabi Defendants (collectively, “Defendants”) resolving the Hatch-Waxman Act concerning Gland’s ANDA filing.

Under the terms of the Settlement Agreement, Plaintiffs granted Defendants a perpetual, royalty-free and fully paid-up, non-exclusive, non-sublicensable, non-transferable right and license solely to make, have made, use, sell, offer to sell, import, and/or distribute the product that is subject to Gland’s ANDA in the United States commencing in the early 2030s, subject to certain exceptions as is customary in these type of agreements.

As required by law, the settlement is subject to review by the U.S.

Department of Justice and the Federal Trade Commission.

Under the Generating Antibiotic Incentives Now (“GAIN”) provisions of the FDA Safety and Innovation Act (“FDASIA”), the FDA may designate a product as a qualified infectious disease product (“QIDP”).

In order to receive this designation, a drug must qualify as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.

We obtained a QIDP designation for the IV formulation of XERAVA ® for cIAI in July 2013.

Upon approving an application for a QIDP, the FDA will extend by an additional 5 years any non-patent marketing exclusivity period awarded, such as a 5-year exclusivity period awarded for an NCE.

This extension is in addition to any pediatric exclusivity extension awarded.

XERAVA ® has been awarded this 5-year exclusivity under FDASIA.

The following table summarizes the status of our primary product candidate:

(1) Global Antibiotic Research and Development Partnership (“GARDP”) fully funded the Phase 3 clinical trial and pharmaceutical development activities and has commercial rights in WHO defined low-income and specified middle-income countries.

We have retained commercial rights in major markets in North America, Europe and Asia-Pacific

Zoliflodacin is a late-stage product candidate, a potential single oral dose cure for the treatment of uncomplicated gonorrhea caused by the bacterial pathogen N.

NUZOLVENCE ® (zoliflodacin) was approved by the U.S.

FDA on December 12, 2025 as a single oral dose cure for the treatment of uncomplicated gonorrhea caused by the bacterial pathogen N.

gonorrhoeae .

Gonorrhea is an area of significant medical need and zoliflodacin is the only novel single dose treatment in development that provides a potential monotherapy oral alternative to intramuscular injections of ceftriaxone for the treatment of gonorrhea, including infections caused by drug-resistant strains.

Zoliflodacin targets the validated mechanism of action of the fluoroquinolone class of antibiotics but does so in a novel manner to avoid existing fluoroquinolone resistance.

Gonorrhea is an area of significant medical need and NUZOLVENCE ® is the only approved novel single dose treatment that provides monotherapy oral alternative to intramuscular injections of ceftriaxone for the treatment of gonorrhea, including infections caused by drug-resistant strains.

NUZOLVENCE ® targets the validated mechanism of action of the fluoroquinolone class of antibiotics but does so in a novel manner to avoid existing fluoroquinolone resistance.

In November 2023, we reported positive top-line data results of a pivotal Phase 3 trial.

The study demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular infection of ceftriaxone and oral azithromycin, a current global standard of care regimen.

We continue to advance zoliflodacin following its successful Phase 3 clinical trial results and expect to submit an NDA to the U.S.

FDA in early 2025.

The study demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin, a current global standard of care regimen.

This trial was initiated in 2019 in collaboration with GARDP, who funded all the Phase 3 clinical trial and pharmaceutical development costs and in return received commercial rights for zoliflodacin in WHO-defined low-income and select middle-income countries.

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Ceftriaxone is administered by intramuscular injection, which can be painful and may require patient monitoring by a healthcare administrator.

Although ceftriaxone remains effective in most of the U.S., in Hawaii and Massachusetts as well as in several countries, including China, Japan, Vietnam, South Korea, France and Spain, N.

gonorrhoeae strains with resistance to azithromycin and ceftriaxone have been reported, prompting concerns that multidrug-resistant gonorrhea may become a major community health issue.

Although ceftriaxone remains effective in most of the U.S., in Hawaii and Massachusetts, N.

gonorrhoeae strains with resistance to azithromycin and ceftriaxone have been reported, and high numbers of resistant strains are now prevalent in many countries across the globe, prompting concerns that multidrug-resistant gonorrhea may become a major community health issue.

Market Opportunity

gonorrhoeae is an immediate global public health threat with 82.4 million cases worldwide in 2020 (WHO estimate).

Cases of gonorrhea in the United States have reached an estimated 1.6 million per year.

The CDC estimates that the cases of gonorrhea in the United States have been increasing at least 10% per year since 2009.

Cases of gonorrhea in the United States are estimated at more than one million per year.

The results of a 2017-2018 survey of countries reporting decreased susceptibility, DS, or resistance, R, of N.

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Non inferiority of zoliflodacin was demonstrated within the pre-specified margin of 12% and, furthermore, within the margin of 10% as specified in U.S.

Food and Drug Administration guidance.

FDA guidance.

Phase 3 trial design

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Phase 2 clinical proof-of-concept trial:

We have completed a multi-center, randomized, open-label Phase 2 clinical trial comparing a single oral dose of 2.0g or 3.0g of zoliflodacin to 500mg intramuscular ceftriaxone for the treatment of uncomplicated gonorrhea.

We completed a multi-center, randomized, open-label Phase 2 clinical trial comparing a single oral dose of 2.0g or 3.0g of zoliflodacin to 500mg intramuscular ceftriaxone for the treatment of uncomplicated gonorrhea.

In this trial, 179 randomized patients received treatment and zoliflodacin was generally well tolerated, with efficacy outcomes comparable to ceftriaxone.

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Preclinical Data

We have generated biochemical, microbiological and in vivo data on zoliflodacin.

We generated biochemical, microbiological and in vivo data on zoliflodacin.

The data suggest that zoliflodacin retains potent activity against contemporary clinical isolates in the U.S., Europe, China, Thailand and South Africa that are resistant to other antibiotic classes including fluroquinolones, which was expected given its novel mechanism of action.

In addition, the data show significant resistance against two of the four standard antibiotics indicated for gonorrhea, ciprofloxacin, a fluoroquinolone, and azithromycin, a macrolide.

We are initially developing zoliflodacin as a single oral dose treatment for uncomplicated gonorrhea.