Heron Therapeutics , Inc .: Heron Therapeutics Announces Fourth Quarter and Full - Year 2025 Financial Results

finanznachrichten.de · Feb 26, 2026 · Collected from GDELT

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- ZYNRELEF- and APONVIE- Drive 65% Year-Over-Year Net Revenue Growth in Acute Care Franchise- Achieved $154.9 Million in 2025 Net Revenue- Issues Full-Year 2026 Net Revenue Guidance of $173 to $183 Million and Adjusted EBITDA of $10 to $20 MillionCARY, N.C., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and twelve months ended December 31, 2025, and highlighted recent corporate updates."As demonstrated in today's release, we are entering 2026 with exceptional momentum. The fourth quarter delivered the strongest results in the history of Heron's Acute Care franchise, underscoring the success of the strategic decisions we implemented to unlock the full potential of these assets," said Craig Collard, Chief Executive Officer of Heron. "The milestones achieved in 2025, particularly for ZYNRELEF - including enhanced distributor-partner incentives, the seamless completion of the Vial Access Needle transition, and CMS approval of a product-specific J-Code - are already accelerating adoption and strengthening our competitive position in a large and underpenetrated market.""With a more powerful commercial engine, expanding demand signals, and improved reimbursement clarity, we believe Heron is well-positioned for continued share gains and meaningful revenue expansion in 2026 and beyond."Financial Guidance for 2026 Item2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions)Net Revenue$173 to $183 millionAdjusted EBITDA$10 to $20 million Business Highlights- Heron's Acute Care franchise delivered revenue growth of 57.3% year-over-year in Q4 2025 and 65.1% year-over-year for 2025 compared to 2024, reflecting continued commercial acceleration.- ZYNRELEF Updates: The permanent, product specific J-Code (J0668) for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services ("CMS"), was approved effective October 1, 2025 - streamlining reimbursement and improving billing clarity across payer types and settings of care.Transition to the Vial Access Needle is complete, optimizing product preparation, handling, and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across the U.S.Through aligned partnerships with leading distributors, we are broadening account access and elevating education around ZYNRELEF's differentiated clinical profile, driving durable surgeon adoption and expansion of use.Development of the proposed Prefilled Syringe market presentation is progressing and, if successful, FDA approval is anticipated in mid-to-late 2027. - APONVIE Updates: Inclusion of APONVIE (aprepitant) Injectable Emulsion in the Newly Released Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting ("PONV"), highlighting the clinical impact of aprepitant, use of multimodal PONV prophylaxis, and expanding recognition of the need for long-acting antiemetic coverage.CMS has granted a permanent, product specific J-Code (J8502) for APONVIE Fully dedicated sales team, launched in Q3 2025, is gaining significant momentum in both expanding formulary access and driving successful utilization of APONVIE. - Oncology Updates: The Oncology franchise continues to deliver a strong revenue base, generating over $105 million in 2025 net revenue despite complex market dynamics. - Cash, cash equivalents, and short-term investments were $46.6 million as of December 31, 2025. Net Revenue Performance - Twelve Months Ended December 31 (in thousands) 20252024Dollar ChangePercentage Change Acute Care- 49,643- 30,064- 19,579 65.1- APONVIE$11,571$4,518$7,053156.1%ZYNRELEF$38,072$25,546$12,52649.0% Oncology- 105,261- 114,221- (8,960- (7.8%)CINVANTI$96,758$100,079$(3,321)(3.3%)SUSTOL$8,503$14,142$(5,639)(39.9%) Total Net Revenue- 154,904- 144,285- 10,6197.4- Net Revenue Performance - Three Months Ended December 31 (in thousands)(unaudited) 20252024Dollar ChangePercentage Change Acute Care- 16,344- 10,389- 5,95557.3- APONVIE$3,814$1,932$1,88297.4%ZYNRELEF$12,530$8,457$4,07348.2% Oncology- 24,244- 30,392- (6,148- (20.2%)CINVANTI$22,917$26,873$(3,956)(14.7%)SUSTOL$1,328$3,519$(2,191)(62.3%) Total Net Revenue- 40,588- 40,781- (193- (0.5%) Conference Call and WebcastHeron will host a conference call and live webcast on Thursday, February 26, 2026, 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 PainZYNRELEF 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") PreventionAPONVIE 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) PreventionCINVANTI, 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 PreventionSUSTOL 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.About Heron Therapeutics, Inc.Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute car