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Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance
HRTXHeron Therapeutics(HRTX) Prnewswire·2024-11-12 12:55

Core Insights - Heron Therapeutics reported a positive year-to-date 2024 Adjusted EBITDA of 1.4millionandexpectsQ42024NetRevenuebetween1.4 million and expects Q4 2024 Net Revenue between 37 million and 43million[1][2]−ThecompanyreceivedFDAapprovalfortheZYNRELEFVialAccessNeedle(VAN)inSeptember2024,withaplannedlaunchinQ42024[1][3]−ZYNRELEFhasbeenincludedintheCMSFinalRuleNon−OpioidPolicyforPainRelief,allowingforseparatepaymentinspecifichealthcaresettings[1][3]FinancialPerformance−ForthethreemonthsendedSeptember30,2024,HeronreportedNetProductSalesof43 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 31.4millionforthesameperiodin2023[26]−TheGrossProfitforthesameperiodwas31.4 million for the same period in 2023 [26] - The Gross Profit for the same period was 23.4 million, up from 13.2millionyear−over−year[26]−ThecompanyreportedaNetLossof13.2 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 25.0millionforthesameperiodin2023[26]ProductSalesHighlights−AcuteCareFranchiseNetProductSalesforthethreeandninemonthsendedSeptember30,2024,were25.0 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 19.7million,respectively,comparedto19.7 million, respectively, compared to 4.7 million and 12.9millionin2023[4]−ZYNRELEFNetProductSalesforthesameperiodswere12.9 million in 2023 [4] - ZYNRELEF Net Product Sales for the same periods were 6.3 million and 17.1million,respectively,comparedto17.1 million, respectively, compared to 4.4 million and 12.0millionin2023[4]−APONVIENetProductSalesforthethreeandninemonthsendedSeptember30,2024,were12.0 million in 2023 [4] - APONVIE Net Product Sales for the three and nine months ended September 30, 2024, were 1.1 million and 2.6million,respectively,comparedto2.6 million, respectively, compared to 0.3 million and 0.9millionin2023[5]GuidanceandFutureOutlook−Thecompanyhasnarroweditsfull−year2024guidanceforProductRevenues,Net,AdjustedOperatingExpenses,andAdjustedEBITDA,withupdatedrangesreflectingimprovedexpectations[3]−TheZYNRELEFVANisexpectedtosimplifyasepticpreparationandreducewithdrawaltimesignificantly,enhancingitsmarketpotential[3]−ZYNRELEFwillcontinuetoreceiveseparatepaymentundertheCMSpolicyuntilatleasttheendof2027,withapaymentlimitationsetat0.9 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]