Heron Therapeutics Inc Stock Price, News & Analysis

Heron Therapeutics (NASDAQ: HRTX) has reached a settlement agreement with Mylan Pharmaceuticals, a Viatris company, regarding patent litigation for CINVANTI® and APONVIE® injectable emulsions. The settlement grants Mylan a license to market generic versions of both drugs in the United States starting June 1, 2032, or earlier under certain circumstances.

The patent litigations were initiated by Heron in September 2023 and January 2024 after Mylan sought FDA approval for generic versions before the Heron Patents' expiration in 2035. Both companies will file for dismissal of the pending litigations with the U.S. District Court for the District of Delaware.

Heron Therapeutics has appointed Mark Hensley as Chief Operating Officer, bringing over fifteen years of pharmaceutical industry experience to the commercial-stage biotech company. Hensley previously served as CEO of Veloxis Pharmaceuticals from 2021 to 2024, and held COO and CCO positions from 2018 to 2021.

As part of his employment package, Hensley will receive significant inducement awards including:

• 500,000 shares stock option
• 500,000 restricted stock units
• Performance-based option for up to 900,000 shares

The compensation structure includes a 4-year vesting schedule for options and RSUs, with performance stock options tied to company stock price goals. CEO Craig Collard emphasized Hensley's role in driving operational efficiency and executing growth initiatives in Heron's next phase.

Heron Therapeutics (HRTX) has announced it will host a conference call and live webcast on Tuesday, May 6, 2025, at 8:00 a.m. ET to discuss its first quarter 2025 financial results and recent business highlights.

Participants are encouraged to dial in fifteen minutes before the scheduled start time to avoid delays. The event will be accessible via phone through a registration link and webcast through the Investor Relations section of Heron's website. A recording will be available on the company's website for 60 days following the call.

Heron Therapeutics (HRTX) reported strong financial results for Q4 and full-year 2024, achieving Q4 GAAP Net Income of $3.6 million and full-year net revenue of $144.2 million, marking a 14% year-over-year increase. The company delivered full-year 2024 adjusted EBITDA of $8.6 million.

Key highlights include ZYNRELEF Q4 2024 net revenue of $8.5 million and the launch of the ZYNRELEF Vial Access Needle (VAN) in December 2024. The company secured a favorable U.S. District Court ruling in a patent lawsuit against Fresenius Kabi USA, upholding CINVANTI patents through 2035.

ZYNRELEF's expanded label indications now cover an estimated 17 million annual targeted procedures. The product will continue receiving separate payment until at least end of 2027 under CMS policy. The newly launched VAN is expected to simplify preparation and reduce withdrawal time to 20-45 seconds.

Heron Therapeutics (HRTX) has announced it will host a conference call and live webcast on Thursday, February 27, 2025, at 8:00 a.m. ET to discuss its fourth quarter and full year 2024 financial results, along with recent business highlights. The company encourages participants to dial in fifteen minutes before the scheduled start time to avoid delays. The webcast will be available under the Investor Relations section of Heron's website, with an archive accessible for 60 days following the call.

Heron Therapeutics (HRTX) announced the relocation of its corporate headquarters from San Diego, California to Cary, North Carolina, effective January 1, 2025. The new headquarters will be located near the Research Triangle Park (RTP), positioning the company within one of the most prominent high-tech R&D parks in the US. The move is strategic as a majority of Heron's Management Team and corporate employees already work from the Cary office.

CEO Craig Collard highlighted that the relocation will centralize operations and resources while facilitating strategic partnerships. The new headquarters will be situated at 100 Regency Forest Drive, Suite 300, Cary, NC 27518. The location provides ample space for growth and expansion within the growing biotech community.

Heron Therapeutics (HRTX) announced a favorable ruling from the U.S. District Court for the District of Delaware in its patent litigation against Fresenius Kabi USA. The court upheld the validity of Heron's patents (U.S. Patent Nos. 9,561,229 and 9,974,794) for CINVANTI® injectable emulsion, which expire in 2035, and found they would be infringed by Fresenius' proposed generic product.

The litigation began in July 2022 after Fresenius submitted an Abbreviated New Drug Application seeking approval for a generic version of CINVANTI®. Heron will now seek a court order to prevent Fresenius from launching its generic version until the patents expire in 2035.

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.