Heron Therapeutics(HRTX)
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Heron Therapeutics(HRTX) - 2022 Q4 - Annual Report
2023-03-29 20:11
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].
Heron Therapeutics(HRTX) - 2022 Q4 - Earnings Call Presentation
2023-03-24 04:49
Product Performance & Sales - ZYNRELEF demand units increased by 38% from Q3'22 to Q4'22[6] - APONVIE launched on March 6, 2023, targeting the PONV prevention market[2, 45] - CINV Franchise net sales increased to $97.5 million in 2022[15] - Total net product sales for the year ended December 31, 2022, were $107.7 million[1, 76] Market & Strategy - ZYNRELEF targets 74 IDNs, representing a potential $149 million Exparel sales opportunity[8] - ZYNRELEF offers acquisition cost savings of 23% to 34% compared to Exparel[13] - APONVIE targets a large market opportunity of 36 million annual procedures in patients at moderate to high risk for PONV[14] Financial Status - Heron had $84.9 million in cash, cash equivalents, and short-term investments as of December 31, 2022[49] - Full-year 2023 CINV Franchise net sales are expected to be in the range of $99 million to $103 million[48] Product Development - A Vial Access Needle (VAN) is being developed to simplify ZYNRELEF withdrawal, with potential availability by mid-2024[20] - A prefilled syringe (PFS) for ZYNRELEF is under development[20, 87]
Heron Therapeutics(HRTX) - 2022 Q4 - Earnings Call Transcript
2023-03-24 01:08
Financial Data and Key Metrics Changes - ZYNRELEF net sales grew to $3.9 million for the fourth quarter, representing a 44% increase over the prior quarter and a 362% increase over the same quarter in the prior year [22] - Total ZYNRELEF unique ordering accounts increased to 793 by the end of the fourth quarter, up from 704 at the end of the third quarter [10] - CINV franchise net sales for the full year 2022 were $97.5 million, a 17% increase over the prior year [99] Business Line Data and Key Metrics Changes - Demand units for ZYNRELEF grew to 20,765 units in the fourth quarter, a 38% increase over the prior quarter and a 301% increase year-over-year [94] - CINVANTI manufacturing is now online, with gross margins increasing from about 50% towards 75% [12] - The oncology care team achieved a 32% increase in net sales for the CINV business compared to the same quarter in the prior year [34] Market Data and Key Metrics Changes - The company reported a branded market share growth of 9.1% in the 66 IDNs with formulary approval, which is about twice the level of the total market [23] - The elimination of separate reimbursement for generic fosaprepitant in the hospital outpatient segment has made CINVANTI's value proposition more attractive [11] - The company is targeting 36 million annual procedures in patients at moderate to high risk of PONV, with an estimated 12 million patients not receiving any prophylaxis [28] Company Strategy and Development Direction - The company is focused on expanding the label for ZYNRELEF and improving the withdrawal process from the vial to enhance growth [92][104] - APONVIE is positioned as a strategic fit for the company, leveraging existing relationships with anesthesia and pharmacy for formulary access [29] - The company aims to increase the number of surgeons using ZYNRELEF and expand into other surgical lines [50] Management's Comments on Operating Environment and Future Outlook - Management noted that the first quarter typically sees a seasonal decline in surgeries, but growth for ZYNRELEF is expected to continue despite this [20] - The company anticipates a label expansion for ZYNRELEF in October, which could drive further growth [42] - Management expressed confidence in the early customer feedback for APONVIE and the potential for significant market opportunity [33] Other Important Information - R&D expenses declined to $11.1 million in the fourth quarter of 2022, down from $28.9 million in the same quarter of 2021 [37] - The company had cash, cash equivalents, and short-term investments of $84.9 million as of December 31, 2022 [51] Q&A Session Summary Question: What is the reason for the increase in accounts receivable? - Management attributed the increase to minor timing in payments and an overall increase in sales throughout the year [39] Question: Can you elaborate on options for shoring up cash runway? - Management indicated they are working with the Board to explore options to extend the cash runway and reduce R&D expenses [60] Question: What are the overall surgical volume trends? - Management noted that January is typically slow, but they have seen good movement in February and strong March, leading to overall growth [70] Question: What is the strategy for increasing uptake from accounts with consistent ordering? - The strategy includes leveraging medical device representatives to strengthen relationships with orthopedic surgeons and ensure product availability [82] Question: What are the regulatory implications for improving ZYNRELEF's product presentation? - Management stated that they are evaluating opportunities to accelerate the approval process through a 510(k) filing, which generally goes faster [78]
Heron Therapeutics (HRTX) presents at 2023 Cowen Conference - Slideshow
2023-03-07 19:00
Forward-Looking Statements Heron Pipeline of 4 Approved Products With $106.7 million in | --- | --- | --- | --- | --- | --- | |---------------|-----------------------------------|-------------|----------|--------------------------------------|----------| | | | PRECLINICAL | CLINICAL | NDA | APPROVED | | | | | | | | | | SUSTOL® (granisetron) | | | US FDA Approved for CINV Prevention* | | | Oncology Care | extended-release injection | | | | | | | CINVANTI® | | | | | | | (aprepitant) injectable emulsion | | | ...
Heron Therapeutics(HRTX) - 2022 Q3 - Earnings Call Transcript
2022-11-09 01:09
Heron Therapeutics, Inc. (NASDAQ:HRTX) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants David Szekeres - EVP and COO Barry Quart - CEO and Chairman John Poyhonen - President and Chief Commercial Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Josh Schimmer - Evercore Serge Belanger - Needham and Company Operator Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q3 2022 Earnings Conference. As a reminder, ...
Heron Therapeutics(HRTX) - 2022 Q3 - Quarterly Report
2022-11-08 21:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-33221 HERON THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other juris ...
Heron Therapeutics(HRTX) - 2022 Q2 - Earnings Call Transcript
2022-08-09 18:05
Heron Therapeutics, Inc. (NASDAQ:HRTX) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants David Szekeres – Executive Vice President, Chief Operating Officer Barry Quart – Chief Executive Officer and Chairman John Poyhonen – President and Chief Commercial Officer Conference Call Participants Josh Schimmer – Evercore Serge Belanger – Needham and Company Operator Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q2 2022 Earnings Confer ...
Heron Therapeutics(HRTX) - 2022 Q2 - Earnings Call Presentation
2022-08-09 14:24
| --- | --- | --- | |-----------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | Heron Update | | | | | | | | Q2 2022 Earnings Call | | | | | | | | | | | Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this presentation, and involve substantial risks a ...
Heron Therapeutics(HRTX) - 2022 Q2 - Quarterly Report
2022-08-09 12:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-33221 HERON THERAPEUTICS, INC. 4242 Campus Point Court, Suite 200 San Diego, CA 92121 (Address of principal executive off ...
Heron Therapeutics(HRTX) - 2022 Q1 - Earnings Call Transcript
2022-05-09 23:56
Heron Therapeutics, Inc. (NASDAQ:HRTX) Q1 2022 Results Conference Call May 9, 2022 4:30 PM ET Company Participants David Szekeres - EVP and COO Barry Quart - Chairman and CEO John Poyhonen - President and Chief Commercial Officer Kimberly Manhard - EVP, Drug Development and Board Director Conference Call Participants Brandon Folkes - Cantor Fitzgerald Josh Schimmer - Evercore ISI Serge Belanger - Needham and Company Boris Peaker - Cowen Kelly Shi - Jefferies Operator Good day, ladies and gentlemen, and than ...