Company: HRTX
Filing Date: 2025-09-09
Form Type: S-3
Source: 0000950170-25-113830
Chunk: 6

Company: HERON THERAPEUTICS, INC. /DE/
Filing Date: 2025-09-09
Form: S-3
Chunk 6
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 ZYNRELEF® (bupivacaine and meloxicam) extended-release solution (“ZYNRELEF”), APONVIE® (aprepitant) injectable emulsion (“APONVIE”), CINVANTI® (aprepitant) injectable emulsion (“CINVANTI”), and SUSTOL® (granisetron) extended-release injection (“SUSTOL” and together with ZYNRELEF, APONVIE and 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 including our co-promotion agreement with CrossLink Network, LLC (“CrossLink Network”);

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

the timing and outcome of our pending patent litigations;

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 clinical trials of our Products and product candidates are indicative of the results in future clinical trials;

our ability to successfully launch our ZYNRELEF Vial Access Needle (“VAN”) in the U.S.;

our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials, and our ability to submit for and obtain regulatory approval for product candidates in our anticipated timing, or at all;

the clinical utility of our Products and product candidates and their potential advantages compared to other treatments;

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

the safety and efficacy results of our clinical trials and other required studies for expansion of the indications for our Products and approval of our product candidates and the data to support such clinical trials, potential regulatory approval or further development of any of our Products or product candidates;

our ability to meet the postmarketing study requirements within the mandated timelines of the U.S. Food and Drug Administration (“FDA”) and to obtain favorable results and comply with standard postmarketing requirements, including U.S. federal advertising and promotion laws, federal and