Heron Therapeutics(HRTX)
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Heron Therapeutics(HRTX) - 2025 Q1 - Quarterly Report
2025-05-06 11:45
Product Approvals and Indications - ZYNRELEF, a dual-acting local anesthetic, is the first modified-release local anesthetic classified by the FDA as an extended-release product, significantly reducing pain and increasing the proportion of patients requiring no opioids post-surgery[96]. - ZYNRELEF received FDA approval for expanded indications in December 2021 and January 2024, and a prior approval supplement for the Vial Access Needle was approved in September 2024[97]. - APONVIE, the first intravenous formulation of an NK1 receptor antagonist for postoperative nausea and vomiting, was approved by the FDA in September 2022 and became commercially available in March 2023[99][100]. - CINVANTI, an IV formulation of aprepitant, is indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic and moderately emetogenic cancer, and was approved by the FDA in November 2017[101][104]. - SUSTOL, the first extended-release 5-HT3 receptor antagonist, is indicated for preventing nausea and vomiting associated with MEC and AC chemotherapy regimens, and was approved by the FDA in August 2016[105][107]. Financial Performance - Net product sales for the three months ended March 31, 2025, were $38.9 million, an increase of 12.4% compared to $34.7 million in 2024[112]. - Acute care net product sales increased by 89.4% or $4.9 million, primarily driven by increased units sold and new customers for ZYNRELEF and APONVIE[113]. - Oncology net product sales decreased by 2.2% during the same period, attributed to market competition[114]. - Gross profit margin improved to 78.3% in Q1 2025 from 75.6% in Q1 2024, despite a 0.2% increase in cost of product sales[115]. - Net income for Q1 2025 was $2.6 million, compared to a net loss of $3.2 million in Q1 2024[123]. - Net cash used in operating activities decreased to $8.9 million in Q1 2025 from $9.5 million in Q1 2024, attributed to improved net income and reduced operating spend[124]. Expenses and Cost Management - Research and development expenses decreased by 50.5% to $2.3 million, primarily due to reduced headcount and development activities[117]. - General and administrative expenses decreased by 15.2% to $12.7 million, mainly due to reduced headcount and legal expenses[118]. - Sales and marketing expenses increased by 7.6% to $12.3 million, reflecting increased spending to support revenue growth in acute care products[119]. Regulatory and Market Considerations - The Centers for Medicare and Medicaid Services approved a 3-year transitional pass-through status for ZYNRELEF effective April 1, 2022, allowing separate reimbursement outside of the surgical bundle payment[98]. - The omnibus spending bill H.R. 2617 includes the NOPAIN Act, directing CMS to provide separate Medicare reimbursement for non-opioid treatments, including ZYNRELEF, from January 1, 2025, through December 31, 2027[98]. - The company faces various risks, including competition, regulatory challenges, and market acceptance of its products, which may impact future performance[92]. Technology and Development Focus - The proprietary Biochronomer Technology allows for sustained release of pharmacological agents over days to weeks with a single administration, enhancing therapeutic delivery[108]. - The company is focused on advancing its product candidates through clinical studies and obtaining regulatory approvals within anticipated timelines[94]. Financial Position - Cash, cash equivalents, and short-term investments totaled $50.7 million as of March 31, 2025, with concerns about refinancing $150 million in Senior Convertible Notes due in May 2026[121].
Heron Therapeutics(HRTX) - 2025 Q1 - Quarterly Results
2025-05-06 11:45
Exhibit 99.1 Heron Therapeutics Announces First Quarter 2025 Financial Results and Highlights Recent Corporate Updates CARY, May 6, 2025 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three months ended March 31, 2025, and highlighted recent corporate updates. "We are off to a strong start in 2025, achieving record adjusted EBITDA for the first quarter. Building on our efforts to strength ...
Heron Therapeutics Announces First Quarter 2025 Financial Results and Highlights Recent Corporate Updates
Prnewswire· 2025-05-06 11:45
Core Insights - Heron Therapeutics reported strong financial results for Q1 2025, achieving record adjusted EBITDA and significant revenue growth driven by its acute care products, particularly ZYNRELEF [2][6][7]. Financial Performance - The company generated net revenue of $38.9 million in Q1 2025, a 12.2% increase compared to Q1 2024 [6][7]. - Adjusted EBITDA for Q1 2025 was $6.2 million, a significant improvement from a loss of $734,000 in Q1 2024 [6][27]. - The acute care segment saw a revenue increase of 89.4%, with ZYNRELEF contributing $8.0 million, up 60.4% from the previous year [5][7]. Business Highlights - The company reached a settlement with Mylan Pharmaceuticals regarding patent litigations for CINVANTI and APONVIE, allowing Mylan to market generics starting June 1, 2032 [6][7]. - The Non-Opioid Policy for Pain Relief, effective April 1, 2025, provides separate payment for non-opioids like ZYNRELEF, enhancing market opportunities [7]. - The launch of the Vial Access Needle (VAN) for ZYNRELEF is progressing well, improving operational efficiency in surgical settings [7]. Financial Guidance - For the full year 2025, the company updated its guidance for net revenue to a range of $153 million to $163 million and adjusted EBITDA to $4 million to $12 million [3][6]. Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $50.7 million [7]. Product Information - ZYNRELEF is the first extended-release dual-acting local anesthetic approved for postoperative pain management, demonstrating significant efficacy in reducing pain and opioid use [9]. - APONVIE is indicated for the prevention of postoperative nausea and vomiting, showing bioequivalence to oral aprepitant [11]. - CINVANTI is used for preventing chemotherapy-induced nausea and vomiting, with a unique IV formulation [13]. - SUSTOL is indicated for the prevention of nausea and vomiting associated with chemotherapy, utilizing a novel drug delivery technology [15].
Heron Therapeutics Announces Settlement with Mylan Related to CINVANTI® and APONVIE® Patent Litigations
Prnewswire· 2025-05-06 11:30
Core Viewpoint - Heron Therapeutics has entered into a settlement agreement with Mylan Pharmaceuticals to resolve patent litigations, allowing Mylan to market generic versions of CINVANTI® and APONVIE® starting June 1, 2032, or earlier under certain conditions [1][2]. Group 1: Settlement Agreement Details - The settlement resolves ongoing patent litigations initiated by Heron in September 2023 and January 2024 against Mylan's applications for generic versions of CINVANTI® and APONVIE® [2]. - Mylan will receive a license under the Heron Patents to market the generic drugs in the U.S. [1][2]. Group 2: Company Background - Heron Therapeutics is a commercial-stage biotechnology company focused on developing therapeutic innovations to improve patient care, particularly in acute care and oncology [3]. - The company utilizes advanced science and patented technologies to create and commercialize a portfolio of products aimed at enhancing the standard of care [3].
Heron Therapeutics Announces Appointment of Mark Hensley as Chief Operating Officer
Prnewswire· 2025-04-28 22:55
Core Insights - Heron Therapeutics, Inc. has appointed Mark Hensley as Chief Operating Officer, bringing over fifteen years of experience in the pharmaceutical industry [1][2] - The CEO of Heron, Craig Collard, expressed confidence in Hensley's ability to drive operational efficiency and support the company's growth initiatives [2] - Hensley previously held senior leadership roles at Veloxis Pharmaceuticals, including CEO and COO, and has a strong background in sales and operations [2] Compensation and Inducement Awards - As part of his employment, Hensley will receive inducement awards including a non-statutory stock option for 500,000 shares, 500,000 restricted stock units, and a performance-based stock option for up to 900,000 shares [3] - The inducement options have a 10-year term with a four-year vesting schedule, with 25% vesting on the first anniversary and the remainder vesting monthly over the next three years [3] - The performance-based stock option vests based on achieving certain stock price goals during Hensley's employment [3] Company Overview - Heron Therapeutics is a commercial-stage biotechnology company focused on developing and commercializing therapeutic innovations to improve patient care [4] - The company utilizes advanced science and patented technologies to create a portfolio of products aimed at enhancing the standard of care for acute care and oncology patients [4]
Heron Therapeutics to Report First Quarter 2025 Financial Results on Tuesday, May 6, 2025
Prnewswire· 2025-04-22 20:05
Company Overview - Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on developing and commercializing therapeutic innovations to improve medical care [3] - The company utilizes advanced science, patented technologies, and an innovative approach to drug discovery and development [3] - Heron aims to advance the standard-of-care for acute care and oncology patients through its portfolio of products [3] Upcoming Events - The company will host a conference call and live webcast on May 6, 2025, at 8:00 a.m. ET to report first quarter 2025 financial results and discuss recent business highlights [1] - Participants can access the conference call via a registration link and are encouraged to join fifteen minutes early to avoid delays [2] - An archive of the teleconference and webcast will be available on Heron's website for 60 days following the call [2]
Are Medical Stocks Lagging Encompass Health (EHC) This Year?
ZACKS· 2025-04-22 14:41
Company Overview - Encompass Health (EHC) is a stock within the Medical sector, which includes 1000 individual stocks and holds a Zacks Sector Rank of 3 [2] - EHC currently has a Zacks Rank of 2 (Buy), indicating a favorable outlook based on earnings estimate revisions [3] Performance Analysis - Over the past 90 days, the Zacks Consensus Estimate for EHC's full-year earnings has increased by 0.9%, reflecting improved analyst sentiment [4] - EHC has gained approximately 4.1% year-to-date, significantly outperforming the average return of -7.4% for Medical companies [4] - In the Medical - Outpatient and Home Healthcare industry, which includes 17 companies, EHC is performing better than the average loss of 5.9% this year [6] Comparative Analysis - Heron Therapeutics (HRTX), another Medical stock, has returned 26.1% year-to-date and has a Zacks Rank of 1 (Strong Buy) [5] - HRTX belongs to the Medical - Drugs industry, which has 162 stocks and has experienced a decline of -7.4% since the beginning of the year [7] - Both Encompass Health and Heron Therapeutics are noted for their solid performance, making them attractive options for investors in the Medical sector [7]
Heron Therapeutics(HRTX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 17:07
Financial Data and Key Metrics Changes - The company achieved a net income of $3.6 million for Q4 2024 and a full-year net revenue of $144.2 million, reflecting a 14% year-over-year increase [10][11] - Adjusted EBITDA for the full year 2024 was $8.6 million, with gross margin improving from 49% to approximately 73% [12][20] - Operating expenses have been reduced by over $80 million since 2022, ending 2024 with a cash balance of just over $59 million [13][24] Business Line Data and Key Metrics Changes - CINVANTI net revenues rebounded to $26.9 million in Q4 2024 from $22.7 million in Q3 2024, with full-year revenues exceeding $100 million [11][12] - ZYNRELEF achieved record net revenues of $8.5 million in Q4 2024, a 33% increase from $6.3 million in Q3 2024 [11][12] - The Oncology franchise, including CINVANTI and SUSTOL, continues to show growth despite increased competition [14] Market Data and Key Metrics Changes - APONVIE and ZYNRELEF saw significant growth, up over 310% and 48% respectively in Q4 2024 compared to the same period last year [15] - The company anticipates continued growth in 2025 as it expands product usage within hospital institutions [16] Company Strategy and Development Direction - The management team has focused on repositioning the business for future growth and achieving profitability by Q4 2024 [8] - The company secured inclusion in the NOPAIN Act, expanding reimbursement for ZYNRELEF, and launched the vial access needle (VAN) to improve product preparation time [9][10] - The CrossLink partnership has been integrated, with over 800 distributor representatives focused on the orthopedic space [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ZYNRELEF's growth potential, especially with the upcoming full implementation of the NOPAIN Act [45] - The company is taking a conservative approach to CINVANTI's outlook due to increased competition and potential pressure on average selling prices [14][38] - Management expects some lumpiness in cash flow and adjusted EBITDA in early 2025 due to legal expenses and other factors [37] Other Important Information - The company incurred inventory write-offs of $2.5 million and asset impairment write-offs of $2.2 million in 2024 [25] - The launch of the 200 mg VAN is expected around April 2025, which is anticipated to further enhance sales [34][60] Q&A Session Summary Question: ZYNRELEF's performance in the quarter - Management confirmed no significant stocking issues and noted that inventory levels were low, with positive reception to the VAN [30][31] Question: Cash flow and adjusted EBITDA expectations - Management indicated that cash flow may be a bit lumpy in early 2025 due to legal expenses but overall results are expected to remain stable [37] Question: Drivers of ZYNRELEF's momentum - Management highlighted the CrossLink partnership and the upcoming NOPAIN Act implementation as key drivers of momentum for ZYNRELEF [49][50] Question: Expectations for ZYNRELEF in Q1 - Management anticipates continued growth in Q1, with daily average sales higher than in Q4, despite seasonal factors [60] Question: Update on the peripheral syringe for ZYNRELEF - The company is pleased with the VAN rollout and expects to launch the prefilled syringe by late 2026 or early 2027 [76]
Heron Therapeutics (HRTX) Q4 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2025-02-27 15:35
Core Insights - Heron Therapeutics reported revenue of $40.78 million for Q4 2024, marking a year-over-year increase of 19.1% and exceeding the Zacks Consensus Estimate of $36.95 million by 10.37% [1] - The company achieved an EPS of $0.02, a significant improvement from -$0.07 a year ago, resulting in an EPS surprise of 166.67% compared to the consensus estimate of -$0.03 [1] Financial Performance - Net Product Sales for the Oncology Care Franchise (Sustol) were $3.52 million, slightly above the estimated $3.38 million, but a decrease of 7.4% year-over-year [4] - Net Product Sales for the Acute Care Franchise (Aponvie) reached $1.93 million, significantly surpassing the estimated $1.43 million, reflecting a year-over-year increase of 311.1% [4] - Net Product Sales for the Acute Care Franchise (Zynrelef) totaled $8.46 million, exceeding the average estimate of $6.88 million, with a year-over-year growth of 48.5% [4] - Net Product Sales for the Oncology Care Franchise (Cinvanti) amounted to $26.87 million, above the estimated $25.40 million, representing a year-over-year increase of 10.7% [4] Market Performance - Shares of Heron Therapeutics have returned +2.4% over the past month, contrasting with the Zacks S&P 500 composite's decline of -2.2% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]
Heron Therapeutics(HRTX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 14:00
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]