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The earnings call highlights strong growth in Acute Care products, particularly ZYNRELEF and APONVIE, with optimistic future guidance and strategic initiatives. Despite some competitive and regulatory challenges, the company exceeded its financial guidance, showing resilience. The Q&A session provided additional positive insights, especially regarding the beneficial impact of the NOPAIN Act and new guidelines for APONVIE. However, some uncertainties remain, such as the litigation outcome and the exact impact timelines. Overall, the strong financial performance and growth potential suggest a positive stock price movement.
Total Net Revenues (2025) $155 million, with a year-over-year increase driven by strong performance in Acute Care products like ZYNRELEF and APONVIE.
Adjusted EBITDA (2025) $14.7 million, exceeding the guidance range of $9 million to $13 million, more than doubling the prior year's performance due to improved cost discipline and product mix.
Gross Margin (2025) Approximately 73%, reflecting continued improvements in cost discipline and product mix.
ZYNRELEF Net Revenue Growth (Q4 2025) 48% year-over-year, driven by sharper distributor execution, workflow simplification, and reimbursement clarity.
APONVIE Net Revenue Growth (Q4 2025) 97% year-over-year, supported by expanded hospital adoption, permanent coding, and inclusion in new guidelines.
Acute Care Franchise Growth (Q4 2025) 57% year-over-year, attributed to strategic initiatives like the CrossLink IGNITE program and improved reimbursement pathways.
Oncology Franchise Net Revenue (2025) $105 million, a 7.8% decline year-over-year, primarily due to the planned wind-down of SUSTOL, while CINVANTI remained resilient.
Acute Care Net Sales (Q4 2025) $16.3 million, up 33% quarter-over-quarter, driven by ZYNRELEF and APONVIE.
Oncology Supportive Care Net Sales (Q4 2025) $24.2 million, reflecting a decline due to SUSTOL's wind-down but supported by CINVANTI's stable performance.
ZYNRELEF: Achieved 48% year-over-year revenue growth in Q4 2025. Contributed significantly to Acute Care net sales increase. Enhanced distributor execution through the CrossLink IGNITE program and improved hospital adoption with a permanent J-Code and vial access needle.
APONVIE: Achieved 97% year-over-year revenue growth in Q4 2025. Expanded hospital adoption with a dedicated sales team and inclusion in the Fifth Consensus Guidelines for PONV management. Supported by a permanent J-Code for reimbursement clarity.
Commercial team expansion: Plans to accelerate the expansion of the commercial team in key U.S. markets starting in 2026. Focus on geographies with strong market access, favorable reimbursement dynamics, and established relationships to maximize near-term productivity.
Financial performance: Generated $155 million in total net revenues for 2025, with adjusted EBITDA of $14.7 million, exceeding guidance. Gross margin was 73%, reflecting cost discipline and favorable product mix.
Oncology franchise: Generated $105 million in net revenue for 2025, with CINVANTI remaining resilient despite competitive pressures. SUSTOL is undergoing a planned wind-down.
Targeted investments: Increasing commercial investments in 2026 to accelerate revenue growth and market penetration. Focused on priority geographies to enhance operating leverage and long-term growth trajectory.
Prefilled syringe development: Advancing the prefilled syringe presentation for ZYNRELEF, targeting FDA approval in mid-to-late 2027.
Financing Challenges: The company faced significant challenges related to financing, which had been an overhang on the company for some time. Although this issue was resolved in 2025, it had previously constrained the business and impacted strategic execution.
Competitive Pressures in Oncology: The Oncology franchise experienced increased competitive pressure, leading to a modest 7.8% decline in net revenue for 2025 compared to 2024. This was particularly evident with the planned wind-down of SUSTOL and pricing dynamics for CINVANTI.
Regulatory and Development Delays: The development of the prefilled syringe presentation for ZYNRELEF requires 12 months of stability testing and a 4- to 6-month regulatory review, delaying potential approval until mid- to late 2027. This timeline could impact the company's ability to capitalize on market opportunities.
Pricing and Reimbursement Dynamics: The company faces challenges related to pricing and reimbursement, particularly in the Oncology segment. While progress has been made in reimbursement clarity for Acute Care products, these dynamics remain a potential risk to revenue growth.
Economic and Strategic Investment Risks: Increased commercial investments in 2026 may temporarily moderate EBITDA growth. While these investments are aimed at accelerating long-term revenue growth, they pose a short-term financial risk.
Acute Care Product Growth: The company expects continued growth in its Acute Care products, ZYNRELEF and APONVIE, into 2026, supported by stronger commercial infrastructure, improved reimbursement pathways, and rising clinical adoption. Investments will be made to expand the commercial team in key markets to accelerate market penetration and revenue growth.
Commercial Investments: Heron plans to increase commercial investments in 2026, focusing on priority geographies with strong market access and favorable reimbursement dynamics. These investments are expected to temporarily moderate EBITDA growth but are aimed at driving long-term revenue acceleration and market penetration.
ZYNRELEF Prefilled Syringe Development: The company is advancing the development of a prefilled syringe presentation for ZYNRELEF, with potential FDA approval anticipated in mid- to late 2027.
Oncology Franchise Outlook: The Oncology franchise, anchored by CINVANTI, is expected to remain stable despite competitive pressures. The planned wind-down of SUSTOL will continue through 2026.
2026 Financial Guidance: Heron projects net product sales of $173 million to $183 million and adjusted EBITDA of $10 million to $20 million for 2026, reflecting continued profitability and commercial expansion.
The selected topic was not discussed during the call.
The earnings call highlights strong growth in Acute Care products, particularly ZYNRELEF and APONVIE, with optimistic future guidance and strategic initiatives. Despite some competitive and regulatory challenges, the company exceeded its financial guidance, showing resilience. The Q&A session provided additional positive insights, especially regarding the beneficial impact of the NOPAIN Act and new guidelines for APONVIE. However, some uncertainties remain, such as the litigation outcome and the exact impact timelines. Overall, the strong financial performance and growth potential suggest a positive stock price movement.
The earnings call presents mixed signals: strong revenue growth in key products like ZYNRELEF and APONVIE, but a significant net loss due to debt extinguishment and increased SG&A expenses. The Q&A highlights uncertainties in competitive pressures and future strategies. Positive elements include revised EBITDA guidance and strategic initiatives, but declining margins and unclear management responses temper optimism. With no market cap data, a neutral reaction is expected.
The earnings call indicates strong financial performance with significant year-over-year revenue growth, improved net income, and reduced expenses. Although there are some uncertainties regarding the adoption of ZYNRELEF post-NOPAIN Act, management's strategic refocusing and partnerships seem promising. The positive financial health, coupled with optimistic future guidance, suggests a favorable stock price movement. Despite the lack of immediate impact from the NOPAIN Act, the overall sentiment is positive, driven by strong financial metrics and strategic initiatives.
The earnings call reflects a positive outlook with strong financial performance, improved EBITDA, and net income. Product growth potential and strategic partnerships, like CrossLink, are expected to enhance sales. While there are risks, such as market competition and litigation, the company has managed to mitigate these through settlements. The Q&A section indicates optimism for future sales momentum and profitability, despite management's vague responses on litigation impacts. Overall, the financial health and strategic initiatives suggest a positive stock price movement over the next two weeks.
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