Company: HRTX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-063971
Chunk: 5

Company: HERON THERAPEUTICS, INC. /DE/
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 2
Chunk 5
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 CINVANTI, our "Products") in the United States (“U.S.”) , and our positioning relative to products that now or in the future compete with our Products or product candidates;

•our estimates regarding the potential market opportunities for our Products and our product candidates, if approved, and our ability to capture the potential additional market opportunity from the expanded ZYNRELEF label approved in the U.S.;

•our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with CrossLink Network, LLC ("CrossLink Network");

•the realization of anticipated benefits from our co-promotion agreement with CrossLink Network;

•the outcome of our pending abbreviated new drug application litigation;

•whether we are required to write-off any additional inventory in the future;

•our ability to establish satisfactory pricing and obtain adequate reimbursement from government and third-party payors of our Products and product candidates that receive regulatory approvals;

•whether study results of our Products and product candidates are indicative of the results in future studies;

•our ability to successfully launch VAN in the US; 

•the potential regulatory approval for, and commercial launch of, our product candidates, if approved;

•our competitors’ activities, including decisions as to the timing of competing product launches, generic entrants, pricing and discounting;

•whether safety and efficacy results of our clinical studies and other required tests for expansion of the indications for our Products and approval of our product candidates provide data to warrant progression of clinical trials, potential regulatory approval or further development of any of our Products or product candidates;