Fluticasone Furoate/Vilanterol Trifenatate

Having recently been selected for the second round of US drug price talks, GSK's chronic obstructive pulmonary disease (COPD) treatments Trelegy Ellipta and Breo Ellipta have received a boost from the Institute for Clinical and Economic Review (ICER) ahead of the start of negotiations.An analysis from the cost watchdog determined that GSK's two inhaled therapies "offer the advantage of requiring only one puff once a day" for the maintenance treatment of COPD. In contrast, comparator generics to Trelegy Ellipta require two inhalers administered twice daily, while for Breo Ellipta, they generally require at least one inhaler twice daily. According to ICER, observational data suggest that patients are more adherent to once-daily therapy, which may lead to fewer COPD exacerbations. The watchdog concluded that Trelegy Ellipta has comparable or incremental net health benefits compared with other generic triple therapies, with the same for Breo Ellipta versus generic inhaled corticosteroid/long-acting beta-agonist dual therapies administered twice daily.Breo Ellipta combines the inhaled corticosteroid fluticasone furoate with the long-acting beta-agonist vilanterol, while Trelegy Ellipta adds the long-acting muscarinic antagonist umeclidinium to this dual regimen. A recent analysis indicated that total Part D Medicare prescription drug costs for Trelegy Ellipta between November 1, 2023, and October 31, 2024, were $5.1 billion, and $1.4 billion for Breo Ellipta.ICER chief executive Sarah Emond noted that the new analysis "will be one of many inputs" considered by the Centers for Medicare & Medicaid Services in negotiations with GSK. "We hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people."

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted select corporate progress and achievements. Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2024 was an exceptional year for Innoviva. Our core royalty portfolio and therapeutics business both delivered strong year-over-year revenue growth. The excellent performance of IST in 2024 – including revenue growth, new product acquisition through partnership, and significant pipeline progress – is a clear validation of our strategy to build a leading commercial business in critical care and infectious disease.” Mr. Raifeld continued, “In 2024, IST’s revenue growth was driven by the successful launch of XACDURO® and a renewed commercial strategy unlocking new opportunities for GIAPREZA®. Additionally, both XACDURO® and XERAVA® received favorable guidelines placement, which has helped increase access to patients. We also added a fourth approved product to our leverageable commercial infrastructure by licensing ZEVTERA® in the U.S., showcasing both our potential to be a preferred commercial partner and the value creation opportunities enabled by the strength of our operating platform.” “Looking ahead, we anticipate another strong year in 2025 highlighted by an NDA submission for zoliflodacin, the launch of ZEVTERA® in mid-2025, and continued growth for our marketed products, with U.S. net product sales forecasted to exceed $100 million. Backed by nearly $400 million cash and receivables, Innoviva is a well-capitalized company focused on continued value creation through disciplined capital deployment and operational excellence,” concluded Mr. Raifeld. Financial Highlights Royalty revenue: Fourth quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $66.0 million and full year was $255.6 million, compared to $69.6 million for the fourth quarter of 2023 and $252.7 million for the full year 2023. 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 ® , $14.7 million from XACDURO ® . 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. Equity and long-term investments: Fourth quarter and full year 2024 changes in fair values of equity and long-term investments of $19.6 million and $123.4 million, respectively, were primarily attributable to share price depreciation of Armata Pharmaceuticals and other equity investments. Net income: Fourth quarter 2024 net income of $20.3 million ($0.32 basic earnings per share) and full year 2024 net income of $23.4 million ($0.37 basic earnings per share) were driven primarily by higher revenue, offset by the negative impact of changes in the fair values of equity investments. Cash and cash equivalents: Totaled $305.0 million. Royalty and net product sales receivables totaled $86.4 million as of December 31, 2024. Key Business and R&D Highlights ZEVTERA ® (ceftibiprole): 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). In the fourth quarter of 2024, Innoviva licensed U.S. commercialization and distribution rights to ZEVTERA ® from Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN). The Company anticipates launching ZEVTERA ® in the U.S. in mid-2025. In the fourth quarter of 2024, Innoviva licensed U.S. commercialization and distribution rights to ZEVTERA ® from Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN). The Company anticipates launching ZEVTERA ® in the U.S. in mid-2025. Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. 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. The Company remains on track to submit the zoliflodacin NDA to the U.S. FDA in early 2025. 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. The Company remains on track to submit the zoliflodacin NDA to the U.S. FDA in early 2025. 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. 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. In July, XACDURO ® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannaii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance. In August, XACDURO ® was nominated for the prestigious Prix Galien USA award for Best Biotechnology Product. 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. In July, XACDURO ® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannaii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance. In August, XACDURO ® was nominated for the prestigious Prix Galien USA award for Best Biotechnology Product. Update on Strategic Healthcare Assets 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. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA®, XACDURO® and ZEVTERA® 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 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 impact of the novel coronavirus (“COVID-19”); 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, 2023 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. 2024 2023 2024 2023 $ 62,520 $ 66,165 $ 241,733 $ 238,846 28,935 19,675 97,492 60,617 351 - 19,486 11,000 91,806 85,840 358,711 310,463 7,165 13,130 36,598 41,040 - - - 1,600 31,326 26,319 115,690 98,232 3,665 2,356 13,654 33,922 6,511 6,510 25,902 21,784 21,256 (9,506 ) 64,253 (77,392 ) (1,666 ) (16,016 ) 59,161 (11,129 ) (5,768 ) (4,786 ) (19,141 ) (15,818 ) 4,749 5,952 22,209 19,157 (126 ) 680 2,997 4,969 67,112 24,639 321,323 116,365 24,694 61,201 37,388 194,098 4,362 (330 ) 13,996 14,376 20,332 61,531 23,392 179,722 $ 0,32 $ 0,97 $ 0,37 $ 2,75 $ 0,26 $ 0,76 $ 0,36 $ 2,20 62,626 63,710 62,726 65,435 84,200 84,995 74,187 86,876 2024 2023 2024 2023 $ 65,975 $ 69,620 $ 255,556 $ 252,669 (3,455 ) (3,455 ) (13,823 ) (13,823 ) $ 62,520 $ 66,165 $ 241,733 $ 238,846 2024 2023 $ 304,964 $ 193,513 86,366 84,075 33,725 40,737 21,719 25,894 107,532 - 514 483 393,957 560,978 69,961 83,784 2,453 2,536 17,905 17,905 208,433 230,335 12,054 - 41,477 3,267 $ 1,301,060 $ 1,243,507 $ 39,507 $ 33,435 3,422 3,422 1,126 1,277 192,028 191,295 256,316 254,939 64,275 71,870 - 563 53,227 11,751 691,159 674,955 $ 1,301,060 $ 1,243,507 2024 2023 $ 188,690 $ 141,064 (63,786 ) (66,761 ) (13,453 ) (171,839 ) $ 111,451 $ (97,536 ) 193,513 291,049 $ 304,964 $ 193,513