Core Viewpoint - Heron Therapeutics' APONVIE® has been included in the Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting (PONV), highlighting its significance in preventing PONV in surgical patients [1][2][3]. Group 1: PONV Guidelines and APONVIE - PONV affects approximately 30% of general surgical patients and up to 80% of high-risk patients, making it a major cause of dissatisfaction post-surgery [2]. - APONVIE is recognized as an NK-1 receptor antagonist for PONV prevention, noted for its long half-life and rapid 30-second IV administration, which allows for quicker onset compared to oral formulations [2][6]. - The guidelines indicate that aprepitant, either alone or in combination therapies, significantly reduces the risk of PONV and is comparable or superior to ondansetron for prophylaxis [2][6]. Group 2: Importance of PONV Management - The release of the PONV Guidelines is timely as more surgeries are performed in outpatient settings, emphasizing the need for effective PONV management to ensure safe recoveries [3]. - The guidelines recommend a multimodal approach for high-risk patients, suggesting the use of three or more agents for prophylaxis [3][4]. - There is a focus on the importance of long-acting antiemetics to extend protection against nausea and vomiting beyond the hospital setting, addressing the risks of post-discharge nausea and vomiting (PDNV) [4][6]. Group 3: Company Overview - Heron Therapeutics is a commercial-stage biotechnology company dedicated to improving patient care through innovative therapeutic solutions [8]. - APONVIE, approved by the FDA in September 2022 and commercially available since March 2023, is positioned as a key product in the company's portfolio aimed at enhancing postoperative recovery experiences [7][8].

Core Insights - Heron Therapeutics is a biotechnology company focused on pain management and cancer treatments, with key products ZYNRELEF and APONVIE showing significant revenue growth due to strategic initiatives [1] Financial Performance - On November 4, 2025, Heron Therapeutics reported an EPS of -$0.10, missing the estimated EPS of -$0.01, marking a decline from the previous year's loss of $0.03 per share, resulting in a negative surprise of 150% [2] - The company's revenue for the quarter was $38.21 million, below the estimated $39.03 million, but represents a 16.5% increase compared to the same period last year; however, it fell short of the Zacks Consensus Estimate of $38.57 million, resulting in a revenue surprise of -0.91% [3] Valuation Metrics - The company has a P/E ratio of approximately -182.81 and a price-to-sales ratio of about 1.13, indicating negative earnings and that investors are paying $1.13 for every dollar of sales; the enterprise value to sales ratio is approximately 2.20 [4] - The debt-to-equity ratio is about -6.48, indicating a significant level of debt relative to equity [4] Future Outlook - Heron Therapeutics remains optimistic about its future, reaffirming its 2025 net revenue guidance of $153 million to $163 million, with an adjusted EBITDA projected between $9 million and $13 million, focusing on new initiatives launched in the third quarter that are positively impacting commercial performance [5]

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Financial Data and Key Metrics Changes - Total net revenues for Q3 2025 were $38.2 million, with year-to-date revenues of $114.3 million, resulting in adjusted EBITDA of $1.5 million for the quarter and $9.5 million year to date [5][21] - Gross margin was 68.8%, down from 71.2% in Q3 2024, primarily due to a one-time write-off of Sustol polymer inventory [6][18] - Net loss for Q3 2025 was $17.5 million, compared to a net loss of $4.8 million in Q3 2024, largely due to an $11.3 million loss on debt extinguishment [20] Business Line Data and Key Metrics Changes - Acute care portfolio net sales were $12.3 million in Q3 2025, up from $10.7 million in Q2 2025, with ZYNRELEF net sales growing 49% year-over-year to $9.3 million [12][16] - APONVIE net sales increased 173% year-over-year to $3 million, reflecting strong growth before the dedicated sales team was fully active [12][14] - Oncology franchise net sales were $25.9 million in Q3 2025, with CINVANTI net sales approximately $24 million, up about 6% year-over-year [15][16] Market Data and Key Metrics Changes - ZYNRELEF's average daily units increased from 882 in Q3 2024 to 1,127 in Q3 2025, with ordering accounts rising from 705 to 833 [13] - APONVIE's average daily units grew from 418 to 998, with ordering accounts increasing from 299 to 405 [14] Company Strategy and Development Direction - The company has implemented initiatives such as the CrossLink Ignite program and the launch of the 200 mg Vial Access Needle to enhance distributor engagement and product adoption [7][10] - The introduction of a permanent product-specific J-code for ZYNRELEF is expected to streamline reimbursement and improve access [9][11] - The company plans to wind down the commercialization of Sustol over the next 12 months while evaluating potential product updates for a possible reintroduction in late 2027 [16][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for ZYNRELEF and APONVIE, indicating a positive trajectory for the business moving forward [10][16] - The company reaffirmed its guidance for net revenue of $153 million to $163 million and adjusted EBITDA of $9 million to $30 million for the year [21] Other Important Information - Cash and short-term investments as of September 30, 2025, were $55.5 million, bolstered by $13.1 million from recent debt and equity transactions [21] - The company is seeing momentum from the No Pain Act, with approximately 75% of ZYNRELEF indicated procedures having some form of coverage [47] Q&A Session Summary Question: October sales increase for ZYNRELEF - Management confirmed an approximate 17-18% month-over-month increase in early October sales for ZYNRELEF [24] Question: Adjusted gross profit margin - Management confirmed that the adjusted gross profit margin, excluding a one-time stocking charge, would be around 74.5% [25][26] Question: Future sales team expansion - Management indicated that they are pleased with the structural changes made and are considering adding to the sales teams based on success in specific regions [35][38] Question: Inventory stocking benefit for ZYNRELEF - Management stated that there was minimal inventory stocking benefit from the launch of the 200 mg Vial Access Needle [39] Question: Long-term outlook for Sustol and Synvonti - Management acknowledged competitive pressures on Sustol and indicated plans to wind down its commercialization while exploring potential updates for a future reintroduction [49] Question: Impact of the No Pain Act - Management noted that momentum is building for the No Pain Act, with commercial payers beginning to provide separate reimbursement [46][47]

127,127,127 Heron Therapeutics, Inc. Q3 2025 Earnings Call November 4, 2025 26,68,148 84,184,72 0,125,195 75,40,108 1 Forward-looking Statements and Non-GAAP Disclosures This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy a ...

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Product Approvals and Indications - ZYNRELEF, a dual-acting local anesthetic, was approved by the FDA in May 2021 and has shown significant pain reduction and opioid-sparing effects post-surgery[111]. - The FDA approved an expansion of ZYNRELEF's indication in January 2024, allowing its use for postsurgical analgesia for up to 72 hours after specific orthopedic procedures[112]. - APONVIE, the first intravenous formulation for postoperative nausea and vomiting, was approved by the FDA in September 2022 and became commercially available in March 2023[115][116]. - CINVANTI, an IV formulation of aprepitant, is indicated for preventing nausea and vomiting associated with highly and moderately emetogenic chemotherapy, and was approved by the FDA in November 2017[117][120]. - SUSTOL, the first extended-release 5-HT3 receptor antagonist, is indicated for preventing nausea and vomiting associated with chemotherapy and was approved by the FDA in August 2016[121][123]. Financial Performance - Net product sales for Q3 2025 were $38,213,000, a 16.3% increase from $32,810,000 in Q3 2024[138]. - Acute care net product sales increased by 67.2% or $4.9 million in Q3 2025 compared to Q3 2024, driven by increased market share and new customers[133]. - Oncology net product sales decreased by 3.4% or $2.8 million during the nine months ended September 30, 2025, primarily due to market competition[135]. - Gross profit margin for Q3 2025 was 68.8%, down from 71.2% in Q3 2024[137]. Expenses and Cash Flow - Research and development expenses decreased by $1.0 million or 22.3% in Q3 2025 compared to Q3 2024, mainly due to reduced contract services[142]. - General and administrative expenses increased by $1.6 million or 13.0% in Q3 2025 compared to Q3 2024, primarily due to new hires[144]. - Other expenses for Q3 2025 were $13.4 million, significantly higher than $0.4 million in Q3 2024, mainly due to a loss on debt extinguishment[149]. - Cash, cash equivalents, and short-term investments totaled $55.5 million as of September 30, 2025[151]. - Net cash used in operating activities increased by 71.2% to $18.4 million for the nine months ended September 30, 2025, compared to $10.7 million in the same period in 2024[153]. - Net cash provided by financing activities increased to $14.2 million for the nine months ended September 30, 2025, up from $0.5 million in the same period in 2024[155]. Corporate Developments - The company plans to wind down the commercialization of SUSTOL over the next 12 months while evaluating potential product updates, with a possible reintroduction as early as late 2027[126]. - The company entered into a Framework Agreement with Patheon for manufacturing and supply, requiring purchases through December 31, 2026[128]. - A recent amendment to the Working Capital Facility Agreement provides for an aggregate principal amount of up to $150 million, extending the maturity date to September 1, 2030[125]. - The company issued $35 million in 2031 Convertible Notes and raised $27.7 million from the sale of common and preferred stock[125]. Accounting and Estimates - There are no material changes to critical accounting estimates during the three and nine months ended September 30, 2025[131].

Financial Performance - Generated Q3 2025 Net Revenue of $38.2 million, a 16.5% increase from Q3 2024, and year-to-date revenue of $114.3 million[7] - Reaffirmed 2025 Net Revenue Guidance of $153 million to $163 million and adjusted EBITDA guidance of $9.0 million to $13.0 million[5] - ZYNRELEF® Net Revenue grew 49% in Q3 2025 compared to Q3 2024, driven by the launch of the Vial Access Needle and enhanced distributor incentives[7] - APONVIE® Net Revenue increased 173% in Q3 2025 compared to Q3 2024, supported by a dedicated sales team[7] - Acute Care franchise revenue grew 67.2% year-over-year in Q3 2025 and 69.2% year-over-year for the first nine months of 2025[8] - Net product sales for Q3 2025 reached $38.213 million, a 16.3% increase from $32.810 million in Q3 2024[32] - Gross profit for Q3 2025 was $26.299 million, compared to $23.352 million in Q3 2024, reflecting a gross margin improvement[32] - The net loss for Q3 2025 was $17.495 million, significantly higher than the net loss of $4.848 million in Q3 2024[32] - Adjusted EBITDA for Q3 2025 was $1.542 million, a recovery from an adjusted EBITDA loss of $0.355 million in Q3 2024[36] Cash and Investments - Cash, cash equivalents, and short-term investments were $55.5 million as of September 30, 2025[11] - Cash and cash equivalents increased to $43.068 million as of September 30, 2025, up from $25.802 million at the end of 2024[34] Inventory and Assets - Inventory increased to $70.025 million as of September 30, 2025, compared to $53.160 million at the end of 2024, indicating potential growth in product availability[34] - Total assets as of September 30, 2025, were $248.950 million, an increase from $233.147 million at the end of 2024[34] Operating Expenses - Total operating expenses for Q3 2025 were $30.392 million, up from $27.810 million in Q3 2024, primarily driven by increased research and development costs[32] Shareholder Information - The weighted average common shares outstanding increased to 170.348 million in Q3 2025 from 152.830 million in Q3 2024[32] Other Significant Events - The permanent J-code for ZYNRELEF went live on October 1, 2025, improving reimbursement and billing clarity[8] - The company reported a significant loss on debt extinguishment of $11.339 million in Q3 2025[32] - CINVANTI unit demand and Net Revenue increased 6% in Q3 2025 compared to Q3 2024[11]

Core Insights - Heron Therapeutics reported financial results for Q3 and the first nine months of 2025, showing significant revenue growth and reaffirming its financial guidance for the year [1][7][3]. Financial Performance - Q3 2025 net revenue reached $38.2 million, a 16.5% increase from $32.8 million in Q3 2024 [7][9]. - Year-to-date revenue for 2025 is $114.3 million, up 10.4% from $103.5 million in the same period of 2024 [10]. - The company reaffirmed its 2025 net revenue guidance of $153 million to $163 million and adjusted EBITDA guidance of $9 million to $13 million [3][7]. Product Performance - ZYNRELEF net revenue grew 49% in Q3 2025 compared to Q3 2024, driven by the launch of the Vial Access Needle and enhanced distributor incentives [7][8]. - APONVIE net revenue surged 173% in Q3 2025 compared to Q3 2024, supported by increased adoption and a dedicated sales team [7][8]. - The Acute Care franchise reported a revenue growth of 67.2% year-over-year in Q3 2025 [8][9]. Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $55.5 million [8]. Corporate Updates - The company launched several new initiatives in Q3 2025 that are positively impacting commercial execution and product demand [2]. - A permanent product-specific J-code for ZYNRELEF was granted, effective October 1, 2025, which is expected to streamline reimbursement processes [8]. Conference Call - Heron will host a conference call and live webcast on November 4, 2025, to discuss these results and updates [11].