29 One of our strategies is to identify and pursue clinical development of product candidates based on our ABC Platform. Our ABC Platform may not produc d e a pipeline of viable product candidates, or our competitors may develop platform technologies that render our ABC Platform obsolete or less attractive. We face sign i ific f ant competit t io t n in an enviro i nment of rapi a d technologi o cal and scientif t ic f change,e and there is a possibili i ty i that our competito t rs may a retain theiri market share with i existing i drugs, g or achieve regu e latory approval befo e re us or develop l therapies that are safe a r, more advanced or more effe f ctiv t e than ours,s which may a negat e iv t elyl impact our abilit i yt to successful f ly l market or commercializ l e any n product candid d at d es t we may a develop l and ulti l ma i tely harm our fina i ncial conditio d n. The development and commercialization of new drug r products is highly competitive. We may face competition with respect to any product candidates that we seek to develop or commercialize in the future from majo a r pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institut t ions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establ a ish collaborative arrangements for research, development, manufact f ur t ing, and commercialization. There are a number of large pharmaceutical and biotechnology companies that are currently pursuing the development of products for the treatment of the retinal diseases for which we have product candidates. Certain of our competitors have commercially approved products for the treatment of retinal diseases that we are pursuing or may pursue in the future, including Roche, Regeneron and Novartis for the treatment of wet AMD, DME, DR and RVO. These drugs r are well establ a ished therapies and are widely accepted by physicians, patients and third-party payors, which may make it difficult to educ d ate these parties on the benefits of switching to any product candidates developed by us. Companies that we are aware are developing and / or commercializing therapeutics in the retinal disease area include large companies with significant financial resources, such as Roche, Novartis, Bayer and Regeneron, AbbVie, Boehringer Ingelheim, Amgen, Johnson & Johnson, and Samsung Bioepis. In addition to competition from other companies targeting retinal indications, any products we may develop may also face competition from other types of therapies, such as gene-editing therapies and drug r delivery devices. Two Lucentis biosimilars were approved in the United States in 2022, and their approval may impact market dynamics and payor policies negatively for our product candidates. Roche’s product, Vabys a mo (faricimab) a received FDA approval for the treatment of wet AMD and DME in January 2022 and received FDA approval for RVO in October 2023. Vabys a mo has gained rapi a d adoption since launch, and we believe it will become an important product in the marketpl t ace. Regeneron’s product, Eylea HD (high dose aflib f ercept) gained FDA approval for the treatment of wet AMD, DME and DR in August 2023. We believe it will become an important therapy in the marketpl t ace given Regeneron’s incumbent position in retinal diseases. Even if our product candidates present a compelling clinical profil f e, we may not be able to market our product candidates as effe f ctively as our competitors. For example, entrenched franchises may seek to impede adoption of our product candidates through significant discounts or rebates. Many of our current or potential competitors, either alone or with their strategic partners, have significantly greater fin f ancial resources and expertise in research and development, manufact f ur t ing, preclinical testing, conducting clinical trials, obtaining regulatory r approvals, and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and establ a ished companies. These competitors also compete with us in recrui r ting and retaining qualifie f d scientific f and management personnel and establ a ishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary r to, or necessary for, our product candidates. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effe f ctive, have fewer or less severe side effe f cts, are more convenient, or are less expensive than any products that we may develop. Furthermore, currently approved products could be discovered to have application for treatment of retinal disease indications, which could give such products significant regulatory r and market timing advantages over any of our product candidates. Our competitors also may obtain FDA, EMA or other regulatory r approval for their products more rapi a dly than we may obtain approval for ours. Additionally, products or technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing any product candidates we may develop against competitors. In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and/or enforceabi a lity of our patents relating to our competitors’ products and our competitors may allege that our products infringe, misappropriate or otherwise violate their intellectua t l property. For more information regarding potential disputes concerning intellectua t l property, see the subs u ection of this Annual Report on Form 10-K titled “Risks Related to Our Intellectua t l Property.”
Kodiak: 2023 Annual Report Page 38 Page 40