Heron Therapeutics Inc. (NASDAQ:HRTX) has announced its Q3 2020 and nine months ended September 30, 2020, financial results and also provided corporate updates.
Heron increases CINV net sales guidance for FY2020
The company reported chemotherapy-induced nausea and vomiting (CINV) franchise net sales of $20 million and $68 million for Q3 and nine months ended September 30, respectively. For the full year, the company expects a drop in new diagnoses, and the patient starts due to the COVID-19 pandemic. However, the company is raising its FY2020 guidance for CINV franchise net product sales to around $85 million from a range of $70-$80 million. Heron ended the quarter with $258.1 million in cash and cash equivalents which Heron hopes will be sufficient to fund operations through 2022.
Barry Quart, the company’s CEO, said that the CINV franchise is progressing well with robust CINVANTI performance against a backdrop of arbitrage and the current global COVID-19 pandemic. He added that based on the strong execution so far, the company is raising its CINV net product sales guidance to $85 million. Barry also said that in Q3 ZYNRELEF received authorization in the EU. The company remains focused on resubmitting HTX-011 NDA in the US soon to deliver the novel non-opioid medicine to postoperative pain patients.
Heron advancing ZYNRELEF for treatment of postoperative pain
The European Commission gave marketing authorization for ZYNRELEF (HTX-011) in September for somatic postoperative pain treatment. This marketing authorization came at the back of the EMA’s positive opinion from the Committee for Medicinal Products for Human Use back in July. The authorization is valid in 27 WU member countries and other European Economic Area countries. Heron is assessing the evolving pharmaceutical environment and developing a coordinated market approach with ZYNRELEF expected to be available to patients across Europe in 2H 2020.
In the US, the company had a successful Type AQ meeting with the FDA regarding HTX-011 for postoperative pain management. The company reached alignment for the resubmission of New Drug Application for HTX-011 in postoperative pain management in Q4 2020.