On November 4, 2025 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and nine months ended September 30, 2025 and recent corporate updates.
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"There were a number of new initiatives launched in the third quarter, and we’re encouraged by the early signs that they’re positively impacting our commercial execution and driving increased demand for our products," said Craig Collard, Chief Executive Officer of Heron.
Financial Guidance for 2025
2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions)
Item Original Q1 Updated
Guidance Q2 Updated
Guidance Q3 Reiterated
Guidance
Net Revenue $153.0 to $163.0
Adjusted EBITDA $0 – $8.0 $4.0 – $12.0 $9.0 – $13.0 $9.0 – $13.0
Business Highlights
Heron’s Acute Care franchise delivered revenue growth of 67.2% year-over-year in Q3 2025 and 69.2% year-over-year for the first nine months of 2025, reflecting continued commercial acceleration.
ZYNRELEF Updates:
ZYNRELEF Net Revenue increased $3.1 million or 49% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $8.5 million or 49% in the nine months ended September 30, 2025 compared to the same period in 2024.
Commercial initiatives include launch of a reorganized, dedicated ZYNRELEF sales team in Q3 2025, and enhanced distributor incentives in select accounts – including both formulary and high potential non formulary accounts – to drive growth and accelerate adoption.
Following a phased roll-out, transition to the VAN is complete, and every unit of ZYNRELEF now includes this enhanced device – optimizing product preparation, handling and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across U.S.
The permanent, product specific J-code for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services, went live effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care.
The ZYNRELEF Prefilled Syringe program is progressing. Stability for this proposed market presentation has commenced and, if successful, approval is anticipated in 2027.
APONVIE Updates:
APONVIE Net Revenue increased $1.9 million or 173% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $5.2 million or 200% in the nine months ended September 30, 2025 compared to the same period in 2024.
We enter Q4 2025 with a seasoned and fully trained APONVIE team leveraging the full range of Heron’s resources to drive adoption within the many health systems and accounts achieved since launch.
Oncology Updates:
CINVANTI unit demand and Net Revenue increased 6% in Q3 as compared to Q3 2024, continuing to hold consistent revenue year-over-year.
Cash, cash equivalents, and short-term investments were $55.5 million as of September 30, 2025.
Net Revenue Performance – Three Months Ended September 30 (in thousands)
2025 2024 Dollar Change Percentage Change
Acute Care $ 12,347 $ 7,385 $ 4,962 67.2%
APONVIE $ 3,034 $ 1,140 $ 1,894 166.1%
ZYNRELEF $ 9,313 $ 6,245 $ 3,068 49.1%
Oncology $ 25,866 $ 25,425 $ 441 1.7%
CINVANTI $ 23,955 $ 22,662 $ 1,293 5.7%
SUSTOL $ 1,911 $ 2,763 $ (852) (30.8%)
Total Net Revenue $ 38,213 $ 32,810 $ 5,403 16.5%
Net Revenue Performance – Nine Months Ended September 30 (in thousands)
2025 2024 Dollar Change Percentage Change
Acute Care $ 33,300 $ 19,676 $ 13,624 69.2%
APONVIE $ 7,758 $ 2,587 $ 5,171 199.9%
ZYNRELEF $ 25,542 $ 17,089 $ 8,453 49.5%
Oncology $ 81,016 $ 83,828 $ (2,812) (3.4%)
CINVANTI $ 73,841 $ 73,205 $ 636 0.9%
SUSTOL $ 7,175 $ 10,623 $ (3,448) (32.5%)
Total Net Revenue $ 114,316 $ 103,504 $ 10,812 10.4%
Conference Call and Webcast
Heron will host a conference call and live webcast on Tuesday, November 4, 2025, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About APONVIE for Prevention of Postoperative Nausea and Vomiting ("PONV") Prevention
APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.
Please see full prescribing information at www.APONVIE.com.
About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL for CINV Prevention
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
(Press release, Heron Therapeutics, NOV 4, 2025, View Source [SID1234659357])