Company: HRTX
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0000950170-25-028374
Chunk: 35

Company: HERON THERAPEUTICS, INC. /DE/
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1A
Chunk 35
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 of drugs; 

•product liability litigation alleging injuries relating to our Products or similar classes of drugs;

•our ability to maintain and defend our patents and trade secrets for our Products and our Biochronomer Technology;

•our ability to continue to have our Products manufactured at commercial production levels successfully and on a timely basis;

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•our ability to scale up manufacturing of our Products to meet commercial requirements;

•the availability of raw materials necessary to manufacture our Products;

•our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network;

•our ability to access third parties to manufacture and distribute our Products on acceptable terms or at all and those third parties’ ability and/or willingness to fully perform their obligations;

•regulatory developments related to the manufacture or continued use of our Products;

•conduct of post-approval study requirements and the results thereof;

•the extent and effectiveness of sales and marketing and distribution support for our Products;

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

•any other material adverse developments with respect to the commercialization of our Products.

Our business will be adversely affected if, due to these or other factors, our commercialization of our Products does not achieve the acceptance and demand necessary to sustain revenue growth. If we are unable to successfully commercialize our Products our business and results of operations will suffer.

If we are unable to develop and maintain sales, marketing and distribution capabilities or enter into agreements with third parties to sell and market our Products, our sales may be adversely affected.

We have established an internal commercial organization for the sale, marketing and distribution of our Products in the U.S. The development of a sales organization to market our Products is expensive and time consuming, and we cannot be certain that we will be able to successfully develop this capacity or that this function will execute as expected. If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and our business and results of operations will suffer. 

Our internal sales and marketing organization is not currently structured or staffed to launch products on an international level and, therefore, we may not be able to successfully commercialize our Products outside of the U.S. In order to commercialize our Products in jurisdictions other than the U.S., we would be required to obtain separate marketing approvals and comply with numerous and varying regulatory requirements in each foreign country. If we decide to seek the