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]

Revenue and Sales Performance - The company reported net product sales from ZYNRELEF, APONVIE, CINVANTI, and SUSTOL, with revenues dependent on various factors including market conditions and customer agreements [306]. - Net product sales for 2024 reached $144.3 million, a 13.6% increase from $127.0 million in 2023 [331]. - Acute care net product sales grew by 57.3% in 2024, driven by increased market share and the commercial launch of APONVIE in March 2023 [331]. - Total acute care net product sales increased by 87.5% in 2023 compared to 2022, indicating strong growth momentum [332]. Expenses and Cost Management - Research and development expenses primarily consist of salaries, stock-based compensation, and costs related to clinical and preclinical development, with all costs expensed in the period incurred [308]. - General and administrative expenses include salaries and related costs for various personnel functions, as well as professional fees for legal and corporate purposes [309]. - Sales and marketing expenses are focused on personnel costs and commercialization efforts related to the company's products [310]. - Research and development expenses decreased by 57.4% in 2024 to $16.7 million, primarily due to restructuring and reduced headcount [337]. - Operating expenses as a percentage of sales decreased across all categories in 2024, with sales and marketing expenses down 30.4% [341]. - Cost of product sales decreased by 40.6% in 2024, primarily due to reduced inventory reserves and improved production efficiency [334]. Financial Position and Cash Management - Cash, cash equivalents, and short-term investments totaled $59.3 million as of December 31, 2024, sufficient to meet anticipated cash requirements for at least one year [345]. - The company has $175.5 million in current indebtedness that will need to be refinanced to fully fund its business plan [345]. - The company invests in marketable securities to preserve capital, maintain liquidity, and maximize yields, with a focus on high credit quality financial institutions [357]. - The investment portfolio includes only marketable securities and instruments with active secondary markets to ensure liquidity [357]. - The company does not expect material impact on operating results from sudden interest rate changes, as it can hold fixed-income investments to maturity [357]. Risks and Economic Factors - The company faces significant risks from global business, political, and macroeconomic conditions, including financial market volatility and potential government shutdowns [304]. - Foreign currency exposure is primarily to fluctuations in the Euro, but the company does not anticipate significant transaction gains or losses at current operational levels [358]. - The company has not engaged in foreign currency hedging to date, and any gains or losses are included in the Consolidated Statements of Operations [358]. - Inflation has not materially impacted the company's business or results of operations during the reporting periods [359]. - Significant adverse changes in inflation could negatively impact future results of operations [359]. Profitability and Loss - The company reported a net loss of $13.6 million in 2024, a significant reduction from a net loss of $110.6 million in 2023 [346]. - Gross profit for 2024 was $105.6 million, significantly up from $61.9 million in 2023, reflecting improved cost management [330]. Revenue Recognition and Inventory Management - Revenue recognition follows the Financial Accounting Standards Board guidelines, ensuring that revenue reflects the transfer of goods or services to customers [316]. - The company monitors inventory levels and may write down obsolete inventory or inventory exceeding expected sales requirements [323]. - Stock-based compensation is estimated using the Black-Scholes model, with assumptions that could impact net loss and net loss per share if changed [327]. Agreements and Collaborations - A five-year co-promotion agreement was established with Crosslink Network to enhance the promotion of ZYNRELEF for orthopedic indications, with compensation based on growth over a predetermined baseline [305].

Financial Performance - Heron achieved Q4 2024 GAAP Net Income of $3.6 million, marking a significant milestone for the company[7]. - Full-year 2024 Net Revenue reached $144.2 million, representing a 14% increase year-over-year[7]. - ZYNRELEF generated Q4 2024 Net Revenue of $8.5 million, with a full-year revenue of $25.5 million, up 44.1% from 2023[7][9]. - Total Net Revenue for Q4 2024 was $40.8 million, a 19.1% increase compared to Q4 2023[10]. - Net product sales for Q4 2024 reached $40,781 million, a 19.5% increase from $34,233 million in Q4 2023[29]. - Gross profit for the twelve months ended December 31, 2024, was $105,637 million, compared to $61,939 million in 2023, reflecting a significant improvement[29]. - The net loss for Q4 2024 was $3,663 million, a substantial improvement from a net loss of $10,724 million in Q4 2023[29]. - Basic and diluted net income per share improved to $0.02 in Q4 2024, compared to a loss of $0.07 per share in Q4 2023[29]. Revenue Guidance and Expectations - The company expects 2025 Net Revenue guidance between $153.0 million and $163.0 million, with Adjusted EBITDA guidance ranging from $0.0 million to $8.0 million[5]. Product Performance - APONVIE's revenue surged by 224.8% year-over-year, reaching $4.5 million in 2024[9]. - Acute Care segment revenue increased by 57.3% year-over-year, totaling $30.1 million in 2024[9]. Market Expansion - The partnership with Crosslink Network is expected to enhance promotional efforts for ZYNRELEF in the orthopedic surgery market[8]. - Expanded label indications for ZYNRELEF now cover approximately 17 million annual targeted procedures, significantly increasing its market potential[8]. Cash and Assets - Cash, cash equivalents, and short-term investments totaled $59.3 million as of December 31, 2024[8]. - Cash and cash equivalents decreased to $25,802 million as of December 31, 2024, from $28,677 million in 2023[31]. - Accounts receivable increased to $78,881 million in 2024, up from $60,137 million in 2023, indicating higher sales volume[31]. - Total assets grew to $233,147 million in 2024, compared to $222,506 million in 2023, reflecting overall growth[31]. Liabilities and Deficits - Current liabilities increased to $91,457 million in 2024, up from $79,685 million in 2023, suggesting increased operational commitments[31]. - The accumulated deficit as of December 31, 2024, was $(1,919,594) million, slightly worsening from $(1,906,014) million in 2023[31]. Cost Management - Total operating expenses decreased to $117,165 million for the twelve months ended December 31, 2024, down from $172,554 million in 2023, indicating cost management efforts[29].

Core Insights - Heron Therapeutics reported a milestone year in 2024, achieving positive net income in Q4 and a full-year net revenue increase of 14% year-over-year, totaling $144.2 million [2][5][27] - The company is positioned for future growth with its product ZYNRELEF, which has expanded label indications and is expected to benefit from new promotional efforts and regulatory approvals [2][6] Financial Performance - Q4 2024 GAAP net income was $3.6 million, compared to a net loss of $10.7 million in Q4 2023 [5][27] - Full-year 2024 adjusted EBITDA was $8.6 million, with a total operating revenue of $144.3 million, up from $127.0 million in 2023 [5][27] - The company generated Q4 2024 net revenue of $40.8 million, a 19.1% increase from $34.2 million in Q4 2023 [8][27] Product Highlights - ZYNRELEF generated Q4 2024 net revenue of $8.5 million, with expanded indications covering approximately 17 million annual procedures [5][6] - The launch of the ZYNRELEF Vial Access Needle (VAN) is expected to simplify preparation and reduce withdrawal time significantly [6] - The U.S. District Court ruled in favor of Heron in a patent lawsuit, upholding the validity of CINVANTI patents, which expire in 2035 [5] Financial Guidance - For 2025, the company projects net revenue between $153 million and $163 million, with adjusted EBITDA ranging from $0 million to $8 million [3]

Core Viewpoint - Heron Therapeutics, Inc. will host a conference call and live webcast on February 27, 2025, to report its fourth quarter and full year 2024 financial results and discuss recent business highlights [1]. Company Overview - Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on developing and commercializing therapeutic innovations aimed at improving medical care for patients [3]. - The company utilizes advanced science, patented technologies, and an innovative approach to drug discovery and development to create a portfolio of products that enhance the standard-of-care for acute care and oncology patients [3]. Conference Call Details - The conference call can be accessed via a registration link that provides dial-in details, and participants are encouraged to join fifteen minutes early to avoid delays [2]. - The call will also be available through a webcast on Heron's website, with an archive accessible for 60 days following the event [2].

Core Points - Heron Therapeutics, Inc. is relocating its corporate headquarters from San Diego, California to Cary, North Carolina, effective January 1, 2025 [2] - The new location is strategically positioned near the Research Triangle Park, a prominent high-tech research and development area, which supports the company's growth and expansion [2] - The move is expected to enhance operational efficiency by centralizing resources and supporting employees, while also facilitating strategic partnerships in the biotech community [5] Company Overview - Heron Therapeutics is a commercial-stage biotechnology company focused on developing and commercializing therapeutic innovations aimed at improving patient care in acute and oncology settings [5] - The company utilizes advanced science, patented technologies, and innovative drug discovery approaches to create a portfolio of products that enhance the standard of care for patients [5]

Core Viewpoint - Heron Therapeutics won a court case against Fresenius Kabi USA regarding its Cinvanti product, affirming the validity of two patents related to the drug [2]. Company Summary - Heron Therapeutics (NASDAQ: HRTX) successfully defended its patents for Cinvanti in a U.S. District Court ruling [2]. - The court's decision is expected to protect Heron's market position and potentially enhance its revenue from Cinvanti, which is used for chemotherapy-induced nausea and vomiting [2]. Industry Context - The ruling may have implications for the broader biotech industry, particularly in the area of patent protections for pharmaceutical products [2]. - The outcome of this case could influence future litigation involving generic manufacturers and brand-name drug companies [2].

Core Viewpoint - The U.S. District Court for the District of Delaware ruled in favor of Heron Therapeutics in its patent litigation against Fresenius Kabi USA regarding the injectable emulsion CINVANTI® (aprepitant), affirming the validity of Heron's patents which expire in 2035 [1][2]. Group 1 - The court found that Fresenius' proposed generic product would infringe on Heron's U.S. Patent Nos. 9,561,229 and 9,974,794 [1][2]. - Heron plans to seek a court order to prevent Fresenius from launching its generic version of CINVANTI® until after the patents expire in 2035 [2]. - The litigation was initiated in July 2022 following Fresenius' submission of an Abbreviated New Drug Application to the FDA for a generic version of CINVANTI® [2]. Group 2 - Craig Collard, CEO of Heron, expressed satisfaction with the court's decision and emphasized the company's commitment to defending its patent estate [3]. - Heron Therapeutics is focused on developing and commercializing therapeutic innovations aimed at improving patient care, particularly in acute care and oncology [4].

Financial Data and Key Metrics Changes - The company reported a revenue growth of over 12% year-to-date, with gross margin improving from 41% to just over 72% and gross profit doubling from $37 million to $75 million [9] - The net loss for Q3 2024 was $4.8 million, a significant reduction from $25 million in Q3 2023, while the year-to-date net loss was $17.2 million compared to $99.8 million in the same period last year [24] - Cash and short-term investments stood at $70.9 million as of September 30, 2024, with a year-to-date cash burn of less than $10 million [24] Business Line Data and Key Metrics Changes - Total acute care net revenues for Q3 were $7.4 million, with ZYNRELEF contributing $6.3 million and APONVIE contributing $1.1 million [12] - The number of accounts ordering APONVIE tripled over the last 12 months, with an average of 652 daily units sold in October, translating to over $7 million in annualized sales [18] - CINVANTI generated net revenues of $22.6 million for the quarter, maintaining around a 20% market share despite competitive pressures [19] Market Data and Key Metrics Changes - The CrossLink partnership is beginning to drive growth for ZYNRELEF, with nearly 40,000 units ordered in CrossLink accounts to date, amounting to roughly $4.4 million in net revenue [14] - The company is adding an average of 21 new CrossLink accounts per month, indicating a positive trend in market penetration [14] Company Strategy and Development Direction - The company is focused on the "One Heron" initiative, integrating business units to sell the entire product portfolio, which has improved efficiency and accountability [16] - The approval of the Vial Access Needle (VAN) and inclusion in the NOPAIN Act are expected to significantly enhance ZYNRELEF's market position [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Q4 2024, providing a net revenue guidance range of $37 million to $43 million based on early successes [8] - The management believes that the NOPAIN Act will create significant awareness and provide a tailwind for ZYNRELEF, especially in the context of opioid alternatives [39] Other Important Information - The company has revised its financial guidance for the year, narrowing the net revenue range to $140 million to $146 million and adjusted EBITDA guidance to a positive range of $2 million to $5 million [25][26] - The Prefilled Syringe program is progressing, with a targeted approval date at the end of 2026 or early 2027 [46] Q&A Session Summary Question: How should the uptake curve for VAN be anticipated? - Management expects the VAN to be in the market by the first week of December, starting with a few accounts to ensure a smooth launch [28] Question: Comments on CINVANTI's sequential decline and outlook for Q4? - Management noted that CINVANTI is in a competitive market and experienced a loss of a large account in Q3, but expects a bounce back in Q4 due to new account wins [32][33] Question: Is the decrease in OpEx a new baseline? - Management clarified that the decrease in OpEx is not a new baseline but a result of timing and efficient management [37] Question: How much of a tailwind can the NOPAIN Act provide? - Management believes the NOPAIN Act will significantly enhance awareness and provide a tailwind for ZYNRELEF, especially in the context of opioid alternatives [39] Question: Update on the development of the Prefilled Syringe? - The Prefilled Syringe program is progressing well, with a targeted approval date at the end of 2026 or early 2027 [46]

For the quarter ended September 2024, Heron Therapeutics (HRTX) reported revenue of $32.81 million, up 4.4% over the same period last year. EPS came in at -$0.03, compared to -$0.17 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $36.4 million, representing a surprise of -9.86%. The company has not delivered EPS surprise, with the consensus EPS estimate being -$0.03.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall ...