Heron Therapeutics(US:HRTX)2025-11-04 13:00Product 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].