Heron Therapeutics(HRTX) - 2022 Q4 - Annual Report

Financial Performance - For the year ended December 31, 2022, net product sales were $107.7 million, an increase of 24.8% compared to $86.3 million for the same period in 2021[342]. - Net product sales of CINVANTI for the year ended December 31, 2022, were $87.3 million, up from $73.5 million in 2021, representing a growth of 18.8%[343]. - Net product sales of ZYNRELEF for the year ended December 31, 2022, were $10.2 million, compared to $2.9 million in 2021, reflecting a significant increase of 251.7%[344]. - The net loss for the year ended December 31, 2022, was $182.0 million, or $1.67 per share, compared to a net loss of $220.7 million, or $2.24 per share in 2021[358]. - As of December 31, 2022, the accumulated deficit was $1.8 billion, with cash, cash equivalents, and short-term investments totaling $84.9 million[352]. Cost and Expense Management - The company expects a decrease in cost of product sales in 2023 due to validated large-scale manufacturing of ZYNRELEF and CINVANTI in Q4 2022[318]. - Research and development expenses are anticipated to decrease in 2023, attributed to the approval of APONVIE and larger-scale manufacturing validations for ZYNRELEF and CINVANTI[321]. - Sales and marketing expenses are expected to decrease in 2023, as 2022 included one-time launch preparation costs for ZYNRELEF[323]. - For the year ended December 31, 2022, the cost of product sales was $54.9 million, an increase from $46.0 million in 2021, including $8.9 million related to the write-off of short-dated ZYNRELEF inventory[345]. - Research and development expenses totaled $107.5 million for 2022, down from $130.8 million in 2021, primarily due to a decrease in personnel costs of $11.5 million[347]. - General and administrative expenses decreased to $37.4 million in 2022 from $40.2 million in 2021, attributed to reduced facility-related costs[348]. - Sales and marketing expenses were $82.5 million for 2022, compared to $87.2 million in 2021, mainly due to lower costs for CINVANTI and SUSTOL commercialization[349]. Cash Flow and Financing - Net cash used in operating activities for 2022 was $146.9 million, a decrease from $203.4 million in 2021, primarily due to changes in working capital[358]. - The company raised $75.1 million from financing activities in 2022, down from $156.0 million in 2021, primarily due to a significant financing event in May 2021[360]. - The company may need to obtain additional funds to meet cash requirements, which could impact operations if not secured[353]. - The company had total purchase obligations of $103.7 million as of December 31, 2022, with $38.7 million due within one year[364]. Product Development and Approvals - The company commenced commercial sales of ZYNRELEF in the U.S. in July 2021, with net product sales impacted by short-dated product returns due to FDA approval delays[344]. - The company is developing HTX-034, a next-generation product candidate for managing postoperative pain[315]. - APONVIE was approved in the U.S. in September 2022 and became commercially available in March 2023[315]. Estimates and Judgments - The company’s financial condition and results of operations are subject to significant estimates and judgments, which may materially affect reported amounts[327].