32 Changes in methods d of manufa u cturing or formulat l io t n of pr f oduct candid d at d es t may a result in additio i nal costst or delay. a As product candidates proceed through preclinical studi t es to late-stage clinical trials towards potential approval and commercialization, our manufac f turing methods and formulation of product candidates may be altered in an effo f rt to optimize manufac f turing processes and results. For example, we have recently created a scale-up formulation of tarcocimab a in a manner that we believe may improve manufactur t ability and usability. However, these changes could cause tarcocimab to perform differently and affe f ct the results of on-going clinical trials or other future clinical trials, and we may need to revert to a prior for f mulation and may be unabl a e to recover the manufac f turing costs of the drug r product. In addition, changes to commercial formulations from those studi t ed clinically could also lead regulatory r authorities to delay the approval of our marketing applications until we can demonstrate through additional clinical data that there is comparability in the bioavailabi a lity of the two different formulations, or they may require us to revert to the prior formulation evaluated clinically. This could delay completion of clinical trials, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of tarcocimab a or any future product candidates and jeopardize our ability to commence sales and generate revenue. Iff in the future,e we are unablel to establis l h sales and marketin t g capabi a litie i s or enter into agreements with i third parties to sell and market any n product candid d at d es t we may a develop, o we may a not be successfu s l in commercializ l ing those product candid d at d es t if and when they are approved.d We do not have a sales or marketing infrastructur t e and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing and commercial suppor u t infrastructur t e to sell, or participate in sales activities with our collaborators for, some of our product candidates if and when they are approved. There are risks involved with both establ a ishing our own commercial capa a bi a lities and entering into arrangements with third parties to perform these services. For example, recrui r ting and training a sales force or reimbursement specialists is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recrui r t a sales force and establ a ish marketing and other commercialization capa a bi a lities is delayed or does not occur for any reason, we would have prematur t ely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our commercialization personnel. Factors that may inhibit our effo f rts to commercialize any approved product on our own include: • our inability to recrui r t and retain adequate numbers of effe f ctive sales, marketing, reimbursement, customer service, medical affa f irs and other suppor u t personnel; • the inability of sales personnel to obtain access to physicians or educ d ate adequate numbers of physicians on the benefits of prescribing any future approved products; • the inability of reimbursement profes f sionals to negotiate arrangements for formulary r access, reimbursement, and other acceptance by payors; • the inability to price our products at a sufficient price point to ensure an adequate and attractive level of profita f bi a lity; • restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population;