Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance

Core Insights - Heron Therapeutics reported a positive year-to-date 2024 Adjusted EBITDA of $1.4 million and expects Q4 2024 Net Revenue between $37 million and $43 million [1][2] - The company received FDA approval for the ZYNRELEF Vial Access Needle (VAN) in September 2024, with a planned launch in Q4 2024 [1][3] - ZYNRELEF has been included in the CMS Final Rule Non-Opioid Policy for Pain Relief, allowing for separate payment in specific healthcare settings [1][3] Financial Performance - For the three months ended September 30, 2024, Heron reported Net Product Sales of $32.8 million, compared to $31.4 million for the same period in 2023 [26] - The Gross Profit for the same period was $23.4 million, up from $13.2 million year-over-year [26] - The company reported a Net Loss of $4.8 million for the three months ended September 30, 2024, compared to a Net Loss of $25.0 million for the same period in 2023 [26] Product Sales Highlights - Acute Care Franchise Net Product Sales for the three and nine months ended September 30, 2024, were $7.4 million and $19.7 million, respectively, compared to $4.7 million and $12.9 million in 2023 [4] - ZYNRELEF Net Product Sales for the same periods were $6.3 million and $17.1 million, respectively, compared to $4.4 million and $12.0 million in 2023 [4] - APONVIE Net Product Sales for the three and nine months ended September 30, 2024, were $1.1 million and $2.6 million, respectively, compared to $0.3 million and $0.9 million in 2023 [5] Guidance and Future Outlook - The company has narrowed its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses, and Adjusted EBITDA, with updated ranges reflecting improved expectations [3] - The ZYNRELEF VAN is expected to simplify aseptic preparation and reduce withdrawal time significantly, enhancing its market potential [3] - ZYNRELEF will continue to receive separate payment under the CMS policy until at least the end of 2027, with a payment limitation set at $2,267.26 [3]