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 ...

Heron Therapeutics (HRTX) came out with a quarterly loss of $0.03 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.17 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this pharmaceutical company would post a loss of $0.04 per share when it actually produced a loss of $0.06, delivering a surprise of -50%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.Heron Therapeutics, which ...

Core Insights - Heron Therapeutics reported a positive year-to-date 2024 Adjusted EBITDA of $1.4 million and expects Q4 2024 Net Revenue between $37 million and $43 million [1][2] - The company received FDA approval for the ZYNRELEF Vial Access Needle (VAN) in September 2024, with a planned launch in Q4 2024 [1][3] - ZYNRELEF has been included in the CMS Final Rule Non-Opioid Policy for Pain Relief, allowing for separate payment in specific healthcare settings [1][3] Financial Performance - For the three months ended September 30, 2024, Heron reported Net Product Sales of $32.8 million, compared to $31.4 million for the same period in 2023 [26] - The Gross Profit for the same period was $23.4 million, up from $13.2 million year-over-year [26] - The company reported a Net Loss of $4.8 million for the three months ended September 30, 2024, compared to a Net Loss of $25.0 million for the same period in 2023 [26] Product Sales Highlights - Acute Care Franchise Net Product Sales for the three and nine months ended September 30, 2024, were $7.4 million and $19.7 million, respectively, compared to $4.7 million and $12.9 million in 2023 [4] - ZYNRELEF Net Product Sales for the same periods were $6.3 million and $17.1 million, respectively, compared to $4.4 million and $12.0 million in 2023 [4] - APONVIE Net Product Sales for the three and nine months ended September 30, 2024, were $1.1 million and $2.6 million, respectively, compared to $0.3 million and $0.9 million in 2023 [5] Guidance and Future Outlook - The company has narrowed its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses, and Adjusted EBITDA, with updated ranges reflecting improved expectations [3] - The ZYNRELEF VAN is expected to simplify aseptic preparation and reduce withdrawal time significantly, enhancing its market potential [3] - ZYNRELEF will continue to receive separate payment under the CMS policy until at least the end of 2027, with a payment limitation set at $2,267.26 [3]

Wall Street analysts forecast that Heron Therapeutics (HRTX) will report quarterly loss of $0.03 per share in its upcoming release, pointing to a year-over-year increase of 82.4%. It is anticipated that revenues will amount to $36.4 million, exhibiting an increase of 15.8% compared to the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted upward by 25% to its current level. This demonstrates the covering analysts' collective reassessment of their initial pro ...

SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, announced today the appointment of Michael Kaseta to its Board of Directors. Mr. Kaseta has an extensive background spanning corporate finance, business strategy, and the commercialization of biopharma products in large pharmaceutical companies and small biotech companies.Mr. Kaseta currently serves as the Chief Financial Officer and Chief Operating Officer of Liquidia Corporation, a bi ...

SAN DIEGO, Oct. 29, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the Company will host a conference call and live webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET to report third quarter 2024 financial results and discuss recent business highlights.The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avo ...