About Innoviva

Innoviva, Inc. (Innoviva) engages in the development and commercialization of pharmaceuticals. The company has a portfolio of royalties and other healthcare assets. The company’s 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). The company sold its 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. The company expanded its portfolio of royalties and innovative healthcare assets 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. The company’s 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. The company’s development pipeline includes medicines for the treatment of bacterial infections, such as its lead asset sulbactam-durlobactam (SUL-DUR). Strategy The company’s strategy focuses on increasing stockholder value by, among other things, maximizing the potential value of its respiratory assets partnered with GSK, optimizing its operations and augmenting capital allocation. Royalty Product Portfolio Relationship with GSK LABA Collaboration In November 2002, the company entered into its LABA Collaboration Agreement with GSK to develop and commercialize once-daily products for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. The collaboration has developed three combination products, two of which the company is still retain rights in. Those two are as follows: 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-daily combination medicine consisting of a LABA, vilanterol (VI), and an inhaled corticosteroid (ICS), fluticasone furoate (FF), and ANORO ELLIPTA (UMEC/VI), a once-daily medicine combining a long-acting muscarinic antagonist (LAMA), umeclidinium bromide (UMEC), with a LABA, VI. 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. Integrated Hospital / Infectious Disease Business Commercial and Marketed Products GIAPREZA (angiotensin II) GIAPREZA (angiotensin II) injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) and by the Great Britain Medicines and Health Care Products Regulatory Agency (MHRA) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system (RAAS), which in turn regulates blood pressure. GIAPREZA is marketed in the U.S. by La Jolla and is marketed in Europe and Great Britain by PAION Deutschland GmbH (PAION) on behalf of La Jolla. 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 complicated intra-abdominal infections (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 the company’s 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, Taiwan, 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 (Everes”). Everest submitted an new drug application (NDA) in China, which was accepted by the China National Medical Products Administration (NMPA) in March 2021. cIAIs are the second most common source of severe sepsis in the ICU (Brun-Buisson et al, JAMA 1995; 274(12):968–974). cIAIs are defined as consequences of perforations of the gastrointestinal tract that result in contamination of the peritoneal space (Solomkin et al, Clinical Infectious Diseases 2018; 69(6):921–929). XERAVA was approved by the U.S. FDA, HSA, EC, MHRA, and DoH based on the results of IGNITE1 and IGNITE4. Sales and Marketing Organization The company employs an experienced sales and marketing team dedicated to the commercialization of GIAPREZA and XERAVA. Customers During the year ended December 31, 2022, 503 hospitals in the U.S. purchased GIAPREZA, and 874 hospitals and other healthcare organizations in the U.S. purchased XERAVA. Competition XERAVA competes with a number of antibiotics that are 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. Regulatory Exclusivity GIAPREZA and XERAVA are New Chemical Entities (NCEs) approved by the U.S. FDA. 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. 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. Patent Nos.: 9,220,745; 9,572,856; 9,867,863; 10,028,995; 10,335,451; 10,493,124; 10,500,247; 10,548,943; 11,096,983; and 11,219,662 (the GIAPREZA Patents), which are listed in the FDA’s Approved Drug Products. Product Candidates SUL-DUR The company’s lead product candidate, SUL-DUR, is a novel IV antibiotic. The product is a combination of sulbactam, a ß-lactam antibiotic, and durlobactam, its novel ß-lactamase inhibitor (BLI) with broad spectrum ß-lactamase coverage including Classes A, C and D, that it is developing for the treatment of a variety of serious infections caused by carbapenem-resistant Acinetobacter. The company has completed three separate Phase 1 clinical trials, including one evaluating the penetration of SUL-DUR into the lung and one in renally impaired patients. Subsequently, the company completed a Phase 2 clinical trial in patients with cUTIs. The company initiated ATTACK, its single Phase 3 registration trial in 2019, that evaluated SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter pneumonia and/or bloodstream infections. The company announced positive top-line Phase 3 data in October 2021 and based on its positive top-line Phase 3 data and the totality of its preclinical and clinical data, it filed a new drug application (NDA) with the FDA in September 2022. The NDA was accepted for filing by the U.S. FDA. The company completed ATTACK, a Phase 3 registration trial of SUL-DUR for the treatment of patients with carbapenem-resistant Acinetobacter infections, with positive top-line data announced in October 2021. On November 30, 2022, the company announced that the U.S. FDA accepted for Priority Review the new drug application (NDA) for SUL-DUR. The FDA is planning to hold an advisory committee meeting to discuss this application. The target PDUFA date (or action date) is May 29, 2023. The company completed a Phase 2 clinical trial in cUTI patients to provide additional safety and pharmacokinetic, or PK, data, as well as efficacy data against carbapenem-resistant pathogens. Eighty patients were randomized to receive either a dose of SUL-DUR or placebo every six hours for seven days. The company submitted an IND for SUL-DUR to the U.S. FDA in June 2017, and the FDA notified it in July 2017 that it could proceed with this program. The FDA granted Fast Track and QIDP designation for SUL-DUR in September 2017 for the treatment of hospital-acquired and ventilator-acquired bacterial pneumonia and bloodstream infections due to Acinetobacter. Zoliflodacin The company’s second late-stage product candidate is zoliflodacin, a potential 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. The company has completed several Phase 1 clinical trials and a Phase 2 clinical trial of zoliflodacin in patients with uncomplicated gonorrhea. The company has retained commercial rights in all other countries, including the major markets in North America, Europe and the Asia-Pacific. In 2019, the company announced the initiation of a global, multi-center Phase 3 registration trial in collaboration with GARDP who is conducting and funding all Phase 3 clinical trial and pharmaceutical development costs. The company has 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. The company has generated biochemical, microbiological and in vivo data on zoliflodacin. Manufacturing Manufacturing of RELVAR/BREOELLIPTA (FF/VI) and ANORO ELLIPTA (UMEC/VI) is performed by GSK. Government Regulation The company is subject to a variety of financial disclosure and securities trading regulations as a public company in the U.S., including laws relating to the oversight activities of the U.S. Securities and Exchange Commission (SEC) and the regulations of the Nasdaq Capital Market, on which its shares of common stock are traded. Intellectual Property GIAPREZA As of February 15, 2023, the licensed intellectual property portfolio relating to GIAPREZA included 12 issued U.S. patents, 2 pending U.S. patent applications, 8 issued foreign patents and 15 pending foreign patent applications. The issued U.S. patents, and patents that may issue from the pending U.S. patent applications, will expire between 2029 and 2034, absent any disclaimers, extensions, or adjustments of patent term. The foreign patents, and patents that may issue from the pending foreign patent applications, will expire in 2034, absent any disclaimers, extensions, or adjustments of patent term. As of February 15, 2023, the intellectual property portfolio relating to GIAPREZA included 3 issued U.S. patents, 8 pending U.S. patent applications, 7 issued foreign patents and 10 pending foreign patent applications. The issued U.S. patents, and patents that may issue from the pending U.S. patent applications, will expire between 2034 and 2044, absent any disclaimers, extensions, or adjustments of patent term. The foreign patents, and patents that may issue from the pending foreign patent applications, will expire between 2034 and 2044, absent any disclaimers, extensions, or adjustments of patent term. XERAVA As of February 15, 2023, the company owned 2 issued U.S. patents, 1 pending U.S. patent application, 17 issued foreign patents and 4 pending foreign patent applications relating to XERAVA. The issued U.S. patents, and the patent that may issue from the pending U.S. patent application, will have an expiration date of August 7, 2029, absent any disclaimers, extensions, or adjustments of patent term. The term of 1 of the U.S. patents has received 508 days of patent term adjustment. The foreign patents, and patents that may issue from the pending foreign applications, will likewise have an expiration date of August 7, 2029, absent any disclaimers, extensions, or adjustments of patent term. As of February 15, 2023, the company also filed applications for Supplementary Protection Certificates based on European Patent No. 2323972 covering the composition of matter and use of XERAVA. Some applications have been granted and others are pending. In addition, as of February 15, 2023, the company also owned 2 issued U.S. patent, 1 pending U.S. patent application and 11 pending foreign patent applications that relate to crystalline forms of eravacycline, any U.S. patent that may issue from the pending patent application will expire in 2037 absent any disclaimers, extensions, or adjustments of patent term. Likewise, any foreign patents that may issue from the pending foreign patent applications will expire in 2037. The company also owned 5 issued U.S. patents, 1 pending U.S. patent application, 32 issued foreign patents and 17 pending foreign patent applications relating to other tetracycline-related intellectual property. Durlobactam The company’s intellectual property portfolio for its durlobactam program contains patent applications directed to compositions of matter for durlobactam and other chemical analogs, as well as methods of making, referred to as synthetic methods, and methods of use and modes of treatment using durlobactam in combination with one or more antibiotic compounds. As of February 15, 2023, the company owned four issued U.S. patents, one pending provisional application, one pending PCT application, 107 issued foreign patents, as well as six pending foreign patent applications, of which two are allowed. The issued foreign patents are in several jurisdictions, including Australia, the European Union, Canada, China, Hong Kong, Israel, India, Japan, Macau, Mexico, New Zealand, the Philippines, the Russian Federation, Singapore, South Africa, South Korea, Taiwan and the United Kingdom. Issued U.S. and foreign patents and patents issuing from pending U.S. and foreign applications will have expiration dates of April 2033 and April 2043. Zoliflodacin The company’s intellectual property portfolio for zoliflodacin contains patent applications directed to compositions of matter for zoliflodacin and other chemical analogs, as well as synthetic methods and methods of use and modes of treatment. As of February 15, 2023, the company owned seven issued U.S. patents, 74 issued foreign patents, as well as two pending foreign patent applications. The issued foreign patents are in several jurisdictions, including Australia, Brazil, Canada, China, Eurasia, the European Union, Hong Kong, India, Israel, Japan, Mexico, New Zealand, the Philippines, Singapore, South Africa, South Korea, Taiwan and the United Kingdom. Issued U.S. and foreign patents and patents issuing from pending U.S. and foreign applications have expiration dates of October 2029, January 2034 and May 2035. Trademarks, Trade Secrets and Know-How The company’s trademark portfolio consists of various registered trademark and service mark rights in several jurisdictions, including the United States, the European Union, Japan, Argentina, Australia, Brazil, Canada, India, Mexico, Norway, the Russian Federation, South Korea, Switzerland, Taiwan, Turkey and the United Kingdom, and pending applications in other jurisdictions. In connection with the ongoing development and advancement of its products and services in the United States and various international jurisdictions, the company routinely seeks to create protection for its marks and enhance their value by pursuing trademarks and service marks where available and when appropriate. Strategic Partnership with Sarissa Capital Strategic Advisory Agreement On December 11, 2020, the company 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 it in order to assist the company in the development and execution of its acquisition strategy intended to diversify its assets and the potential sources of revenue. Partnership Agreement On December 11, 2020, Innoviva Strategic Partners LLC, the company’s wholly owned subsidiary (Strategic Partners), entered into a 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). History The company was incorporated in Delaware in 1996 under the name Advanced Medicine, Inc. and began operations in 1997. The company changed its name to Theravance, Inc. in 2002. Further, the company changed its name to Innoviva, Inc. in 2016.