Ceftobiprole Medocaril Sodium

Total revenue increases by 14% to CHF 119 million Operating profit increases by 32% to CHF 32 million and net profit by 77% to CHF 28 million Fosmanogepix phase 3 program on track for data readout and regulatory submission in 2028 Raising full-year 2026 guidance: operating profit growth of 40%, driven by increase in total revenues Conference call and webcast today at 4 p.m. (CEST) Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 18, 2026 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharma company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today its results for the first half year 2026. David Veitch, Chief Executive Officer, stated: “Our half-year results demonstrate the successful execution of our strategy across both our commercial and R&D portfolio. We have continued to focus on our key value drivers, with Cresemba maintaining its market leadership position in invasive fungal infections and the progress of the phase 3 program for our key asset fosmanogepix. We also continue to prepare for the initiation of the phase 3 program for our antibiotic ceftibuten-ledaborbactam. Our operational progress is underscored by the continued support from the Biomedical Advanced Research and Development Authority, BARDA, which has awarded additional non-dilutive funding for these two clinical programs this year.” He continued: “Beyond these late-stage programs, we are focusing on creating future value by advancing our earlier-stage pipeline. A highlight was the award of additional non-dilutive funding from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, CARB-X, for BAL2420, as we initiated the first phase 1 study. Our research collaborations with Prokaryotics and Phare Bio are progressing too, advancing innovative approaches to developing the next generation of antifungal and antibacterial therapies. With a growing portfolio that spans commercial products, late- and early-stage development programs and promising research projects, we remain firmly on track to achieve our goal of being a leading anti-infectives company with four commercial assets by 2030 and strong long-term growth prospects.” Adesh Kaul, Chief Financial Officer, said: “We delivered a strong financial performance in the first half-year. Global in-market sales of Cresemba by our partners increased by 27% year-on-year to USD 782 million for the twelve months from April 2025 to March 2026. Following the launch of Zevtera in the US in July of last year, and with market access enabled, we are now seeing increasing numbers of hospitals ordering across the US. In addition, our commercial partner Innoviva Specialty Therapeutics recently expanded its commercial infrastructure to further broaden hospital coverage, which will also benefit Zevtera. Our strong operational execution allows us to significantly increase our operating profit guidance for full-year 2026, and gives us confidence that we are fully on track to deliver on our cash flow targets under Basilea’s Agenda 2030.” He added: “We continue to invest in the future of Basilea. R&D expenditure increased in line with the progress of the phase 3 fosmanogepix program, the preparations for the phase 3 development of ceftibuten-ledaborbactam and the start of the phase 1 clinical study of BAL2420. We made these investments while improving profitability, reducing financial debt and further expanding our net cash position. This combination of strong cash flows from our commercial business and a strong balance sheet provides us with the financial flexibility to advance our phase 3 pipeline, progress our earlier stage programs and pursue additional external growth opportunities, in order to remain one step ahead as outlined in our Agenda 2030.” Financial summary In the first half year (H1) 2026, Basilea reported total revenue of CHF 119.0 million (H1 2025: CHF 104.0 million), an increase of 14.4% year-on-year. Royalty income rose to CHF 57.8 million (H1 2025: CHF 52.1 million), up 10.9% year-on-year, mainly driven by continued strong market demand for Cresemba. Product revenue amounted to CHF 29.9 million (H1 2025: CHF 31.5 million). Milestone and upfront payments totaled CHF 4.7 million (H1 2025: CHF 6.9 million). Other revenue increased to CHF 26.7 million (H1 2025: CHF 13.5 million). This included CHF 22.3 million revenue related to the contracts with BARDA [ 1 ] (H1 2025: CHF 11.1 million) and CHF 1.7 million revenue related to the contract with CARB-X [ 2 ] (H1 2025: CHF 1.9 million). BARDA revenue is based on activities related to the fosmanogepix phase 3 program, the antifungal BAL2062, the close-out of the ceftobiprole phase 3 program, and ceftibuten-ledaborbactam, while CARB-X revenue is based on activities related to the antibiotic BAL2420. In H1 2026, Basilea invested CHF 54.0 million (H1 2025: CHF 38.3 million) in R&D, mainly related to the two ongoing phase 3 clinical studies of fosmanogepix in invasive yeast and mold infections. It also includes expenses related to preparations for the upcoming phase 3 program of ceftibuten-ledaborbactam in complicated urinary tract infections, which is planned to start mid next year. Additionally, it includes expenses for the phase 2 preparation for BAL2062, the phase 1 study for BAL2420, and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 18.0 million (H1 2025: CHF 17.4 million) and cost of products sold amounted to CHF 15.4 million (H1 2025: CHF 24.2 million). Basilea recorded an operating profit of CHF 31.6 million (H1 2025: CHF 24.0 million), an increase of 31.7% year-on-year. The net profit increased by 76.6% year-on-year to CHF 27.9 million (H1 2025: CHF 15.8 million), resulting in basic and diluted earnings per share of CHF 2.26 and CHF 2.13, respectively (H1 2025: basic and diluted earnings per share CHF 1.29 and CHF 1.26, respectively). In H1 2026, Basilea presented a positive operating cash flow of CHF 19.0 million (H1 2025: CHF 23.1 million). The decrease compared to the previous year’s period was mainly driven by a temporary increase in receivables and inventory because of the growing commercial business and strong operational execution. The Company repurchased senior unsecured convertible bonds, due July 2027, in the amount of CHF 5.0 million nominal value in the first half of 2026, further reducing its debt to CHF 71.0 million nominal value as of June 30, 2026. Since the beginning of 2022, Basilea has reduced its total financial debt by approximately CHF 150 million. Cash, cash equivalents and restricted cash increased by 32.6% to CHF 176.0 million as of June 30, 2026 (June 30, 2025: CHF 132.7 million). Furthermore, Basilea increased its net cash position to CHF 105.3 million as of June 30, 2026 (June 30, 2025: CHF 50.7 million). Key financial figures (in CHF million, except per share data) H1 2026 H1 2025 Product revenue 29.9 31.5 Contract revenue 62.4 59.0 Other revenue 26.7 13.5 Total revenue 119.0 104.0 Cost of products sold (15.4) (24.2) Research & development expenses (54.0) (38.3) Selling, general & administrative expenses (18.0) (17.4) Total cost and operating expenses (87.4) (79.9) Operating profit 31.6 24.0 Profit before taxes 32.1 19.3 Income taxes (4.2) (3.5) Net profit 27.9 15.8 Net cash provided by operating activities 19.0 23.1 Basic earnings per share, in CHF 2.26 1.29 Diluted earnings per share, in CHF 2.13 1.26 (in CHF million) June 30, 2026 June 30, 2025 Cash and cash equivalents and restricted cash 176.0 132.7 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2026 can be found on the Company’s website at . Raised 2026 financial guidance: increase in total revenue driving 40% increase in operating profit Basilea provides the following updated guidance for the full year (FY) 2026 versus FY 2025: (in CHF million / percent) FY 2026 updated guidance FY 2026 previous guidance FY 2025 actuals Total revenue ~15% increase ~10% increase 232.4 Research & development expenses ~20% increase ~20% increase 105.9 Operating profit ~40% increase ~20% increase 51.5 Cresemba and Zevtera-related revenue is now expected to increase to CHF ~210 million (versus CHF ~200 million previous guidance) with a continued shift towards higher margin contract revenue, which results in an expected increase of cash contribution to CHF ~180 million from the commercial business. While maintaining investment levels in R&D as planned, Basilea expects the operating profit to increase by ~40% (versus ~20% increase in previous guidance). Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 18, 2026, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: . Please note that there is no function to ask questions via webcast. For asking questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 50 00 (Switzerland, Europe and RoW) +1 (1) 631 570 56 13 (USA) +44 (0) 203 059 58 63 (UK) Replay The webcast, along with the presentation, will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. Save the date – Basilea Capital Markets Day on October 28, 2026, in Zurich The event will provide the audience with a comprehensive update on the company’s strategic direction and value drivers and will include presentations from senior management and external experts. Further details on the agenda and registration will follow. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com . Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This ad hoc announcement can be downloaded from . References The U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), provided partial funding with federal funds for Basilea’s ceftobiprole phase 3 program under contract number HHSO100201600002C. This funding covered approximately USD 111 million, or about 75% of the costs for the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities, and non-clinical work. BARDA is also supporting Basilea’s fosmanogepix and BAL2062 programs under OTA number 75A50124C00033, and the ceftibuten-ledaborbactam program under contract number 75A50123C00050. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. Attachment Press release (PDF)

WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics (IST), a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced today that three of the company’s infectious disease therapies, XACDURO ® (sulbactam/durlobactam for injection), ZEVTERA ® (ceftobiprole medocaril sodium for injection), and NUZOLVENCE ® (zoliflodacin) are finalists for the 2026 Prix Galien USA Award in the Best Pharmaceutical Product category. This marks the third consecutive year an Innoviva Specialty Therapeutics product has been recognized by the renowned Galien Foundation. “This is the broadest slate of IST products to be designated as Prix Galien finalists, which is a testament to the clinical significance of the IST portfolio,” said Pavel Raifeld, Chief Executive Officer of Innoviva, Inc. “Each of these therapies addresses a distinct front in the fight against drug-resistant infections, and this nomination is further validation of our efforts to deliver life-saving medicines to patients.” The Prix Galien award is widely regarded as the industry’s equivalent of the Nobel Prize, recognizing groundbreaking advancements in the biopharmaceutical and medical technology industries that demonstrate the potential to significantly improve human health. The 2026 Award winners will be announced during a ceremony on October 29, 2026, in New York City. “As the public health crisis of antimicrobial resistance (AMR) further progresses, innovative therapeutics will continue to play an outsized role,” said David Altarac, MD, Chief Medical Officer at Innoviva Specialty Therapeutics. “To that end, considering that AMR is estimated to be associated with significant morbidity and millions of deaths worldwide each year, we’re privileged to be recognized for making notable strides in providing treatment for such difficult-to-treat infections.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); XACDURO, approved by the FDA in May 2023, remains the only antibiotic specifically approved for hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex, a pathogen the World Health Organization classifies as a critical-priority drug-resistant threat. ZEVTERA became in April 2024 the first cephalosporin approved by the FDA in nearly two decades for adults with Staphylococcus aureus bloodstream infections (bacteremia), including methicillin-resistant strains (MRSA), and is also indicated for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adult and pediatric patients. NUZOLVENCE, approved by the FDA in December 2025, is a first-in-class, single-dose oral therapy for drug-resistant urogenital gonorrhea, developed through IST’s collaboration with the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organization. About The Prix Galien USA Award The Prix Galien was created in France in 1970 in honor of Galen, the father of medical science and modern pharmacology. The Galien Foundation oversees and directs activities in the U.S. for the Prix Galien Awards, which includes the biennial Prix Galien International Awards. To qualify for a Prix Galien USA Award, each candidate must have been an FDA-approved product for marketing within the last five years and demonstrate tremendous potential to improve human health. The nominating committee does not consider sales data when selecting award nominees; they consider science and health impact. About ZEVTERA ® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus , including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA ® and Mabelio ® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA ® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae . Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae , Haemophilus parainfluenzae , Escherichia coli , and Klebsiella pneumoniae . Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications : ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. About XACDURO ® XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved 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 ( Acinetobacter ). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter . Current US FDA approved XACDURO ® INDICATION & USAGE Indication XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Contraindications : XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or . Before administering, please see the Full Prescribing Information for XACDURO . About NUZOLVENCE® (zoliflodacin) for oral suspension NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. 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. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae . Important Safety Information (ISI) Indication and Usage Indication 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. Usage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Contraindications Known history of hypersensitivity to NUZOLVENCE. Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy. Warnings and Precautions Embryo-Fetal Toxicity: Potential Risk for Pregnant Females Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential. Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential: Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration. Testicular Toxicity and Risks to Male Fertility: Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility. Hypersensitivity Reactions: Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures. Clostridioides difficile Infection (CDI): CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. Development of Drug-Resistant Bacteria: Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed. Drug Interactions Concomitant use with moderate or strong CYP3A4 inducers is contraindicated. Use in Specific Populations Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861. Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur. Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE. Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE. Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE. Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established. Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Reporting Adverse Events You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics™ 1-800-651-3861 medinfo@istx.com U.S. Food and Drug Administration 1-800-FDA-1088 About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliates, include GIAPREZA ® (angiotensin II), XERAVA ® (eravacycline), XACDURO ® (sulbactam for injection; durlobactam for injection), and NUZOLVENCE ® (zoliflodacin). Innoviva Specialty Therapeutics also markets ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva Specialty Therapeutics, please visit . Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR ® /BREO ® ELLIPTA ® , ANORO ® ELLIPTA ® , GIAPREZA ® , XERAVA ® , XACDURO ® , ZEVTERA ® and NUZOLVENCE ® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the development of the LYNX ® platform; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward looking statements on account of new information, future events or otherwise, except as required by law. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica International AG, Allschwil. Contacts Investor and Media Contact Irwin Tendler Head of Investor Relations Executive Director, Corporate Development investors.relations@inva.com