Heron Therapeutics(HRTX) - 2025 Q2 - Quarterly Results

Company Announcement & Executive Summary Q2 2025 Financial Results and Commercial Progress Heron Therapeutics announced Q2 2025 results, highlighting strong core product expansion and capital restructuring for enhanced financial flexibility - Heron Therapeutics announced its financial results and recent corporate updates for the three and six months ended June 30, 2025[3] - The company completed a comprehensive capital restructuring, reducing total debt from $175 million to $145 million and extending debt maturities to at least 2030, enhancing financial flexibility to support growth[6] CEO Commentary CEO Craig Collard stated the company enters Q3 with strong momentum, focusing on accelerating core product expansion and driving sustainable growth for stakeholders - CEO Craig Collard stated the company enters Q3 with strong momentum, clearly focused on accelerating core product expansion[4] - The company is committed to executing strategic priorities, driving sustainable growth, and creating long-term value for stakeholders[4] Financial Performance and Outlook 2025 Financial Guidance Heron Therapeutics reaffirmed 2025 net revenue guidance and raised Adjusted EBITDA guidance, reflecting confidence in future performance Full-Year 2025 Net Revenue and Adjusted EBITDA Guidance (Millions of US Dollars) | Item | Original | Q1 Updated Guidance | Q2 Updated Guidance | | :--- | :--- | :--- | :--- | | Net Revenue | $153.0 to $163.0 | | | | Adjusted EBITDA | $0 - $8.0 | $4.0 - $12.0 | $9.0 - $13.0 | - Reaffirmed 2025 net revenue guidance of $153 million to $163 million[6] - Raised full-year 2025 Adjusted EBITDA guidance from $4 million-$12 million to $9 million-$13 million[6] Key Financial Highlights The company reported strong Q2 2025 net revenue and record year-to-date Adjusted EBITDA, with significant acute care growth Q2 2025 and Year-to-Date Key Financial Data | Metric | Q2 2025 | YTD 2025 | | :--- | :--- | :--- | | Net Revenue | $37.2 million | $76.1 million | | Adjusted EBITDA | - | $7.9 million (record) | - Acute Care franchise revenue grew 55.5% year-over-year in Q2 2025 and 70.5% year-over-year for the first half[7] - ZYNRELEF unit demand increased 6.3% quarter-over-quarter in Q2 2025[6][7] - APONVIE unit demand increased 19% quarter-over-quarter in Q2 2025[6][7] - Cash, cash equivalents, and short-term investments totaled $40.6 million as of June 30, 2025[7] Net Revenue Performance This section details the company's Q2 and H1 2025 net revenue by product line, showing strong acute care growth and oncology product decline Three Months Ended June 30 Total net revenue for Q2 2025 increased 3.3% to $37.2 million, driven by 55.5% acute care growth and a 9.0% decline in oncology products Net Revenue Performance for the Three Months Ended June 30 (Thousands of US Dollars) | | 2025 | 2024 | Dollar Change | Percentage Change | | :--- | :--- | :--- | :--- | :--- | | Acute Care | $ 10,653 | $ 6,851 | $ 3,802 | 55.5% | | APONVIE | $ 2,464 | $ 1,020 | $ 1,444 | 141.6% | | ZYNRELEF | $ 8,189 | $ 5,831 | $ 2,358 | 40.4% | | Oncology | $ 26,547 | $ 29,173 | $ (2,626) | (9.0%) | | CINVANTI | $ 24,143 | $ 24,927 | $ (784) | (3.1%) | | SUSTOL | $ 2,404 | $ 4,246 | $ (1,842) | (43.4%) | | Total Net Revenue | $ 37,200 | $ 36,024 | $ 1,176 | 3.3% | Six Months Ended June 30 Total net revenue for H1 2025 increased 7.7% to $76.1 million, with 70.5% acute care growth and a 5.6% decline in oncology products Net Revenue Performance for the Six Months Ended June 30 (Thousands of US Dollars) | | 2025 | 2024 | Dollar Change | Percentage Change | | :--- | :--- | :--- | :--- | :--- | | Acute Care | $ 20,954 | $ 12,290 | $ 8,664 | 70.5% | | APONVIE | $ 4,724 | $ 1,446 | $ 3,278 | 226.7% | | ZYNRELEF | $ 16,230 | $ 10,844 | $ 5,386 | 49.7% | | Oncology | $ 55,149 | $ 58,404 | $ (3,255) | (5.6%) | | CINVANTI | $ 49,886 | $ 50,544 | $ (658) | (1.3%) | | SUSTOL | $ 5,263 | $ 7,860 | $ (2,597) | (33.0%) | | Total Net Revenue | $ 76,103 | $ 70,694 | $ 5,409 | 7.7% | Consolidated Statements of Operations Heron Therapeutics reported a Q2 2025 net loss of $2.381 million, significantly narrowed, and achieved a net income of $0.254 million for H1, reversing the prior year's loss Consolidated Statements of Operations Key Data (Thousands of US Dollars, except per share amounts) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Net product sales | $ 37,200 | $ 36,024 | $ 76,103 | $ 70,694 | | Gross profit | $ 27,343 | $ 25,506 | $ 57,789 | $ 51,732 | | Total operating expenses | $ 28,980 | $ 31,951 | $ 56,272 | $ 62,975 | | Net (loss) income | $ (2,381) | $ (9,235) | $ 254 | $ (12,395) | | Basic net (loss) income per share | $ (0.02) | $ (0.06) | $ 0.00 | $ (0.08) | | Diluted net (loss) income per share | $ (0.02) | $ (0.06) | $ 0.00 | $ (0.08) | Consolidated Balance Sheets As of June 30, 2025, total assets were $232.09 million, with increased current liabilities due to note reclassification and improved stockholders' deficit Consolidated Balance Sheets Key Data (Thousands of US Dollars) | | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 16,516 | $ 25,802 | | Short-term investments | $ 24,117 | $ 33,481 | | Total current assets | $ 210,923 | $ 209,014 | | Total assets | $ 232,090 | $ 233,147 | | Total current liabilities | $ 258,601 | $ 91,457 | | Total liabilities | $ 259,348 | $ 266,798 | | Total stockholders' deficit | $ (27,258) | $ (33,651) | U.S. GAAP to Non-GAAP Reconciliation: Adjusted EBITDA The company achieved positive Adjusted EBITDA in Q2 and H1 2025, significantly improving year-over-year and reflecting enhanced operational efficiency Adjusted EBITDA Reconciliation (Thousands of US Dollars) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Net (loss) income | $ (2,381) | $ (9,235) | $ 254 | $ (12,395) | | Other expense, net | 744 | 2,790 | 1,263 | 1,152 | | Depreciation | 611 | 641 | 1,162 | 1,330 | | Stock-based compensation | 2,797 | 4,570 | 5,308 | 7,945 | | Adjusted EBITDA | $ 1,771 | $ (1,234) | $ 7,987 | $ (1,968) | Business and Product Updates Acute Care Franchise Performance Heron's Acute Care franchise achieved strong year-over-year revenue growth in Q2 and H1 2025, driven by commercial execution and product adoption - Heron's Acute Care franchise revenue grew 55.5% year-over-year in Q2 2025 and 70.5% year-over-year for the first half[7] ZYNRELEF Updates ZYNRELEF unit demand grew 6.3% in Q2 2025, with commercialization accelerated by sales team restructuring and a new permanent J-code from CMS - ZYNRELEF unit demand increased 6.3% quarter-over-quarter in Q2 2025[6][7] - Commercial plans include launching a restructured ZYNRELEF-dedicated sales team in Q3 2025 and enhancing distributor incentives for specific customers[7] - Transition to Vial Access Needle ("VAN") to be completed in Q3 2025 to optimize product preparation and handling[7] - CMS granted ZYNRELEF a permanent, product-specific J-code, effective October 1, 2025, to simplify reimbursement for hospitals and ambulatory surgical centers[7] - ZYNRELEF is the first and only extended-release dual-acting local anesthetic proven in Phase III studies to significantly reduce pain and increase the proportion of opioid-free patients for up to 72 hours post-surgery[12] APONVIE Updates APONVIE unit demand grew 19% in Q2 2025 due to hospital adoption, with a dedicated sales team launched to expand its PONV prevention market share - APONVIE unit demand increased 19% quarter-over-quarter in Q2 2025[6][7] - A dedicated sales team launched July 1 to focus on APONVIE promotion, leveraging recent access gains to cover approximately 4 million annual surgical patients in the U.S. at moderate-to-high risk for postoperative nausea and vomiting[7] - APONVIE is a Substance P/Neurokinin-1 (NK1) Receptor Antagonist (RA) indicated for the prevention of postoperative nausea and vomiting (PONV) in adults[14] CINVANTI Product Information CINVANTI is an intravenous NK1 receptor antagonist, used with other antiemetics for preventing acute and delayed nausea and vomiting from cancer chemotherapy - CINVANTI, in combination with other antiemetics, is indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy (HEC) and moderately emetogenic cancer chemotherapy (MEC) in adults[16] - CINVANTI is an intravenous formulation of aprepitant, the first intravenous formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules[16] SUSTOL Product Information SUSTOL is an extended-release injectable 5-HT3 receptor antagonist, using Biochronomer® technology, for preventing acute and delayed nausea and vomiting from chemotherapy - SUSTOL, in combination with other antiemetics, is indicated for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens in adults[18] - SUSTOL is an extended-release injectable 5-HT3 receptor antagonist, utilizing Heron's Biochronomer® drug delivery technology, maintaining therapeutic levels of granisetron for at least 5 days[18] Corporate Information and Disclosures Conference Call and Webcast Heron Therapeutics will host a conference call and webcast on August 8, 2025, at 8:30 AM ET to discuss company results and provide details - Heron will host a conference call and webcast on Friday, August 8, 2025, at 8:30 AM ET[11] - Conference call dial-in details are available via a registration link, and the webcast can be accessed on the Investor Relations section of Heron's website[11] About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on developing therapeutic innovations to improve patient lives in acute care and oncology - Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving patient lives through the development and commercialization of therapeutic innovations[20] - The company leverages advanced science, proprietary technologies, and innovative approaches to deliver a portfolio of products for acute care and oncology patients[20] Non-GAAP Financial Measures Explanation The company uses non-GAAP financial measures like Adjusted EBITDA to supplement GAAP results, providing insights into operational activities, with detailed definitions and limitations - The company uses non-GAAP financial measures, such as Adjusted EBITDA, to supplement GAAP results, providing insights into normal operating activities[21][22] - Adjusted EBITDA is a non-GAAP financial measure representing GAAP net income or loss, adjusted for interest expense, interest income, income tax benefit or provision, depreciation, amortization, stock-based compensation expense, and other adjustments not representative of ongoing operations[23] - Adjusted EBITDA has limitations, such as excluding depreciation and amortization, stock-based compensation expense, working capital requirements, income taxes, and cash requirements for capital expenditures or contractual commitments[24][25] - Adjusted Operating Expenses is a non-GAAP financial measure representing GAAP operating expenses, adjusted for stock-based compensation expense, depreciation and amortization, and other adjustments not representative of ongoing operations[26] Forward-looking Statements This press release contains forward-looking statements based on management's expectations, subject to risks and uncertainties that could cause actual results to differ materially - This press release contains “forward-looking statements” based on management’s expectations and assumptions, subject to risks and uncertainties that could cause actual results to differ materially[27] - Examples of forward-looking statements include potential market opportunities for ZYNRELEF, APONVIE, CINVANTI, and SUSTOL, financial guidance, potential market opportunities for ZYNRELEF label expansion, and outcomes of the company’s patent litigation[27] - Important risk factors are detailed in the company’s latest Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission[27] Investor Relations and Media Contact This section provides detailed contact information for Heron Therapeutics' Investor Relations and Media Contact for further communication - Investor Relations and Media Contact: Ira Duarte, Executive Vice President, Chief Financial Officer[34] - Contact: iduarte@herontx.com, 858-251-4400[34]