ADDED
As of February 13, 2026, there were 188,537,136 shares of the Company s common stock ($0.01 par value) outstanding.
In some cases, you can identify forward-looking statements by the use of the words "anticipate," "assume," "believe," "could," "estimate," "expect," "intend," "may," "might," "project," "should," "will," "would," and other expressions that predict or indicate future events and trends and which do not relate to historical matters.
Food and Drug Administration ("FDA") and to obtain favorable results and comply with standard postmarketing requirements, including U.S.
3 PART I In this Annual Report on Form 10-K, all references to "Heron," the "Company," "we," "us," "our" and similar terms refer to Heron Therapeutics, Inc.
ZYNRELEF is approved for use in adults for postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgical procedures including foot and ankle, and other orthopedic surgical procedures in which direct exposure to articular cartilage is avoided.
In September 2024, the FDA approved the prior approval supplement ("PAS") application for ZYNRELEF Vial Access Needle ("VAN"), which is replacing the current vented vial spike.
Through March 31, 2025, ZYNRELEF was reimbursed outside of the surgical bundle payment in the Hospital Outpatient Department ("HOPD") setting of care through pass-through status granted by the Centers for Medicare and Medicaid Services ("CMS").
Effective April 1, 2025, ZYNRELEF is reimbursed through inclusion in the Non-Opioids Prevent Addiction in the Nation ("NOPAIN") Act, which directs CMS to provide separate Medicare reimbursement for non-opioid treatments that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers.
Effective October 1, 2025, CMS has approved a new permanent Healthcare Common Procedure Coding System J-code for ZYNRELEF.
ZYNRELEF will continue to qualify under the Non-Opioid Policy for Pain Relief with the J-code and will be reimbursed outside the surgical supply package for Medicare, aligning with the policy goals to remove financial barriers to qualifying non-opioid pain management options.
REMOVED
As of February 13, 2025, there were 152,329,588 shares of the Company s common stock ($0.01 par value) outstanding.
We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.
In some cases, you can identify forward-looking statements by the use of the words believe, expect, anticipate, intend, estimate, project, will, would, could, should, may, might, plan, assume and other expressions that predict or indicate future events and trends and which do not relate to historical matters.
Factors that might cause these differences include the following: our ability to successfully commercialize, market and achieve market acceptance of 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.
Food and Drug Administration ( FDA ) and to obtain favorable results and comply with standard postmarketing requirements, including U.S.
3 PART I In this Annual Report on Form 10-K, all references to Heron, the Company, we, us, our and similar terms refer to Heron Therapeutics, Inc.
ZYNRELEF is approved for small-to-medium open abdominal, lower extremity total joint arthroplasty, soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.
In September 2024, the FDA approved our Prior Approval Supplement Application for ZYNRELEF Vial Access Needle ("VAN"), which will replace the current vented vial spike.
In March 2022, the Centers for Medicare and Medicaid Services ( CMS ) approved a 3-year transitional pass-through status of ZYNRELEF, which became effective on April 1, 2022, for separate reimbursement outside of the surgical bundle payment in the Hospital Outpatient Department ( HOPD ) setting of care.
2617, the omnibus spending bill was approved by Congress, which includes the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act which directs CMS to provide separate Medicare reimbursement for non-opioid treatments that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers.