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]

Financial Data and Key Metrics Changes - The company achieved a net income of $3,600,000 for Q4 2024 and net revenues of $144,200,000 for the full year, reflecting a 14% year-over-year increase [8][14] - Adjusted EBITDA for the full year was $8,600,000, with gross margin improving from 48.8% to approximately 73% [9][14] - Operating expenses have been reduced by over $80,000,000 since 2022, with cash balance at the end of 2024 exceeding $59,000,000 [10][14] Business Line Data and Key Metrics Changes - Cinvanti net revenues rebounded to $26,900,000 in Q4 from $22,700,000 in Q3, with full-year revenues exceeding $100,000,000 [8][9] - Zenerife achieved record net revenues of $8,500,000 in Q4, a 33% increase from Q3 [9] - The oncology franchise, including Cymbanti and Sustol, continues to show growth despite competition, with Cymbanti generating approximately $100,000,000 in net revenues for 2024 [10][11] Market Data and Key Metrics Changes - The acute hospital segment saw significant growth, with APONAVY and ZENOLAF increasing over 31048% in Q4 compared to the same period last year [11] - Daily unit sales for ZinnerLab are steadily increasing, with onboarding of new accounts at a faster rate [12] Company Strategy and Development Direction - The company aims to achieve profitability and has successfully expanded product labeling for XENOLF, doubling the number of approved procedures [5][6] - The CrossLink partnership has been integrated, focusing on the orthopedic space with over 800 distributor representatives [6][10] - The company is taking a conservative approach to Cymbanti's outlook for 2025 due to increased competition and potential pressure on average selling prices [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2025, particularly with the launch of the VAN and the No Pain Act, which expands reimbursement for Zener Lev [6][11] - The company anticipates continued growth in unit sales, although it may come at lower price points due to market dynamics [10][28] Other Important Information - The U.S. District Court ruled in favor of the company in a patent lawsuit against Fresenius Kabi, upholding the validity of the Symvante patents [8] - The company incurred inventory write-offs of $2,500,000 and asset impairment write-offs of $2,200,000 during the year [14] Q&A Session Summary Question: Any updates on Zenerleaf's performance and future expectations? - Management confirmed no significant stocking issues and noted that the reception of the VAN has been exceptional, with at least 15 accounts returning or saved due to the launch [21][22] Question: How should cash flow and adjusted EBITDA be viewed on a quarterly basis? - Management indicated that there may be some lumpiness in cash flow due to legal expenses and other factors, but overall results are expected to remain stable [27] Question: What is driving the momentum for ZINRILOF? - The CrossLink relationship is contributing significantly, with accounts growing at a higher rate when overlapping with CrossLink representatives [36][37] Question: Expectations for OpEx in 2025? - OpEx is expected to be slightly higher due to increased R&D spending and legal expenses, but overall, the remaining business will remain flat [39] Question: Any thoughts on Baker Brothers debt? - Management plans to meet with Baker Brothers soon to discuss options regarding the convertible debt, especially after resolving litigation uncertainties [48][50]