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Heron Therapeutics, Inc. (Nasdaq: HRTX) is a leading commercial-stage biotechnology company focused on enhancing patient care through the development and commercialization of innovative therapeutic solutions. Specializing in the use of its proprietary Biochronomer™ polymer-based drug delivery platform, Heron is revolutionizing the pharmaceutical landscape by converting daily injectable drugs into weekly or bi-weekly regimens.
The company's product portfolio includes APONVIE, SUSTOL, ZYNRELEF, and CINVANTI, which target unmet medical needs in both acute care and oncology settings. APONVIE is effective in preventing postoperative nausea and vomiting, offering a quick 30-second IV push that is bioequivalent to oral aprepitant. SUSTOL utilizes Heron's Biochronomer® technology to extend therapeutic levels of granisetron for over five days, aiding in the prevention of chemotherapy-induced nausea and vomiting (CINV).
ZYNRELEF, a dual-acting local anesthetic combining bupivacaine and meloxicam, is notably the first extended-release local anesthetic demonstrating superior pain management and reducing opioid use for up to 72 hours post-surgery. Originally approved by the FDA in May 2021, its indication was expanded in January 2024 to cover various soft tissue and orthopedic surgeries. Recently, Heron submitted a Prior Approval Supplement (PAS) for a Vial Access Needle to streamline ZYNRELEF's preparation process, potentially enhancing its adoption in clinical settings.
CINVANTI, an IV formulation of aprepitant, significantly reduces both acute and delayed phases of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy, improving overall patient quality of life during treatment.
Financially, Heron Therapeutics is on a robust trajectory, having implemented a cost reduction program projected to save approximately $75 million through 2025. The company has secured $30 million in equity financing and a $50 million working capital facility, aiming to achieve profitability with its current operational strategies.
Heron’s strong focus on clinical excellence and strategic partnerships, such as its recent collaboration with CrossLink Life Sciences to expand ZYNRELEF's sales network, underscores its commitment to delivering substantial value and improving patient outcomes. For more detailed information, visit herontx.com.
Heron Therapeutics reported positive YTD 2024 Adjusted EBITDA of $1.4 million and narrowed its financial guidance for Q4 2024. The company expects Q4 2024 Net Revenue between $37-43 million. Key developments include FDA approval of ZYNRELEF's Vial Access Needle in September and its inclusion in CMS Final Rule Non-Opioid Policy for Pain Relief. For Q3 2024, acute care franchise sales reached $7.4 million, while oncology care franchise reported $25.4 million. The company's cash position stood at $70.9 million as of September 30, 2024.
Heron Therapeutics (HRTX) has appointed Michael Kaseta to its Board of Directors. Kaseta currently serves as CFO and COO of Liquidia and brings extensive experience in corporate finance, business strategy, and biopharma product commercialization. His previous roles include CFO positions at Aerami Therapeutics and Aralez Pharmaceuticals, as well as CFO at Sanofi North America, where he managed a $10 billion business across eight therapeutic areas. Kaseta holds a BBA in accounting from James Madison University and is a CPA.
Heron Therapeutics (HRTX) has scheduled its third quarter 2024 financial results conference call and webcast for Tuesday, November 12, 2024, at 8:00 a.m. ET. The event will include a discussion of recent business highlights. Participants are encouraged to dial in fifteen minutes before the start time to avoid delays. The webcast will be available under the Investor Relations section of Heron's website, with a replay accessible for 60 days following the call.
Heron Therapeutics (Nasdaq: HRTX) has reaffirmed its ability to supply CINVANTI®, SUSTOL®, and APONVIE® as alternatives during a potential shortage of intravenous (IV) fluids caused by Hurricane Helene. These products are ready-to-administer formulations that don't require additional dilution with IV fluids, making them important during this potential shortage.
The IV fluid shortage is expected due to the temporary closure of a major supplier's manufacturing site in Marion, North Carolina, which reportedly supplies up to 60% of the U.S. IV fluid market. Heron has received outreach from several health systems preparing to maintain continuity of care. The company is committed to ensuring timely delivery of its products throughout the U.S. during this potential shortage.
Heron Therapeutics (Nasdaq: HRTX) announced FDA approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle (VAN). The VAN, expected to launch in Q4 2024, aims to simplify aseptic preparation and reduce withdrawal time to 20-45 seconds. It replaces the current vented vial spike with a user-friendly 'container-like' design, potentially enhancing safe use, increasing adoption, and improving preparation.
Bill Forbes, EVP and Chief Development Officer, highlighted the VAN's potential to address adoption hurdles and reduce preparation time. CEO Craig Collard noted that the VAN approval, along with ZYNRELEF's label expansion, inclusion in the proposed 2025 NOPAIN Act, and partnership with CrossLink Life Sciences, are key milestones for ZYNRELEF's progress in 2024.
Heron Therapeutics (Nasdaq: HRTX) has appointed Brett Fleshman as Chief Business Officer. With 25 years of experience in corporate and business development, commercial strategy, and marketing, Fleshman is expected to drive inorganic revenue growth and expand investor relations. CEO Craig Collard emphasized the timing for adding substantial BD and M&A experience to the management team.
Fleshman's background includes roles at NovaQuest Capital Management, Veloxis Pharmaceuticals, and Cornerstone Therapeutics, where he contributed to successful turnarounds and acquisitions. His focus has been on developing efficient strategies for commercializing new products and revitalizing distressed assets. Fleshman's appointment aims to leverage Heron's established commercial team in hospital and community settings.
Heron Therapeutics (Nasdaq: HRTX) announced its Q2 2024 financial results, reporting Net Product Sales of $36.0 million, up from $31.8 million in Q2 2023. The ZYNRELEF VAN PDUFA goal date is set for September 23, 2024, with anticipated launch before year-end. The company's adjusted operating expenses guidance for 2024 is narrowed to $107.0-$111.0 million, and adjusted EBITDA guidance is revised to $(10.0) to $3.0 million. ZYNRELEF is also included in the proposed 2025 NOPAIN Act, effective April 1, 2025.
For the six months ended June 30, 2024, acute care franchise net product sales were $12.3 million, up from $8.3 million in 2023. Oncology care franchise net product sales were $58.4 million, up from $53.1 million for the same period in 2023.
Heron continues to train CrossLink sales reps for ZYNRELEF, with 561 reps trained to date. The company’s financial efficiency is improving, with increasing revenues and decreasing expenses.
Heron Therapeutics (Nasdaq: HRTX), a commercial-stage biotechnology company, has announced it will host a conference call and live webcast on Tuesday, August 6, 2024, at 4:30 p.m. ET to report its second quarter 2024 financial results and discuss recent business highlights. Investors and interested parties can access the call by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally, using the passcode 1737564. A webcast will also be available under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will be accessible on the company's website for 60 days following the call.
Heron Therapeutics announced that ZYNRELEF, its non-opioid pain relief product, is included in the proposed 2025 Non-Opioid Policy for Pain Relief under Medicare's OPPS and ASC payment systems. This inclusion, effective April 1, 2025, allows ZYNRELEF to maintain separate reimbursement in hospital outpatient departments and ambulatory surgical centers without disruption after its current pass-through payment status expires on March 31, 2025.
The proposed rule by CMS qualifies ZYNRELEF based on its postoperative pain indication and potential to reduce opioid use. For 2025, CMS proposed that payments for qualifying drugs like ZYNRELEF will remain at average sales price plus six percent. Heron expects most commercial payers to follow CMS's policy, potentially expanding access to non-opioid postsurgical pain management options.
Heron Therapeutics (Nasdaq: HRTX) announced that the FDA accepted its Prior Approval Supplement (PAS) application for ZYNRELEF® (bupivacaine and meloxicam) with a goal decision date of September 23, 2024. The new Vial Access Needle (VAN) aims to replace the current vented vial spike, simplifying preparation and reducing withdrawal time from up to three minutes to 20-45 seconds. If approved, VAN is expected to be available in Q4 2024. Additionally, Heron’s partnership with CrossLink Life Sciences aims to bolster ZYNRELEF's promotion by adding approximately 650 representatives by year’s end, targeting orthopedic surgeons nationwide.
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