Business
Heron Therapeutics Announces Second Quarter 2024 Financial Results and Narrows Financial Guidance
Second quarter Net Product Sales of $36.0 million, which increased from $31.8 million for the same period in 2023ZYNRELEF® Vial Access Needle ("VAN") PDUFA
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"Second quarter Net Product Sales of $36.0 million, which increased from $31.8 million for the same period in 2023ZYNRELEF® Vial Access Needle (\"VAN\") PDUFA goal date set for September 23, 2024ZYNRELEF included in the proposed 2025 Non-Opioid Policy for Pain Relief (\"NOPAIN Act\")SAN DIEGO, Aug. 6, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (\"Heron\" or the \"Company\"), a commercial-stage biotechnology company, today announced financial results for the three and six months ended June 30, 2024, and highlighted recent corporate updates.\n\"We have had an exciting start to 2024 with many encouraging milestones that provide the foundation for ongoing commercial success. We are improving the financial efficiency of the business by growing revenues, improving margins, and reducing expenses. Regarding ZYNRELEF, we continue to expand our partnership with CrossLink and progress our regulatory activities in anticipation of a fourth quarter launch of the VAN,\" said Craig Collard, Chief Executive Officer of Heron.\nBusiness Highlights\nThe range for adjusted operating expenses guidance for 2024 is being narrowed from $108.0 million to $116.0 million to a revised $107.0 million to $111.0 million. Additionally, the range for adjusted EBITDA guidance is being narrowed from $(22.0) million to $3.0 million to a revised $(10) million to $3.0 million.The ZYNRELEF VAN PDUFA goal date is set for September 23, 2024. The VAN is designed to allow for easier and more efficient preparation and administration of ZYNRELEF in the operating room, with anticipated launch before year-end.Our development program for the ZYNRELEF Prefilled Syringe (\"PFS\"), which will allow for immediate use of ZYNRELEF, continues to progress with an expected U.S. Food and Drug Administration (\"FDA\") submission for approval in 2026.ZYNRELEF is included in the proposed 2025 NOPAIN Act under the Medicare hospital Outpatient Prospective Payment System (\"OPPS\") and the Medicare Ambulatory Surgical Center (\"ASC\") payment system (the \"Proposed Rule\") as a qualifying product effective April 1, 2025. The Proposed Rule's April 1, 2025 effective date for ZYNRELEF is expected to allow ZYNRELEF to maintain separate reimbursement in the HOPD and ASC settings without disruption.The training and integration of CrossLink sales representatives to promote ZYNRELEF ...