Heron Therapeutics(HRTX)

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Heron Therapeutics(HRTX) - 2023 Q4 - Earnings Call Presentation
2024-03-13 03:21
2 Gross margin improvement from the 50% range historically to over 70% Completed capital raise - $30M in Equity and $50M in debt, pulled down $25M ($55M in total); Current cash and cash equivalents/investments at the end of December was over $80M 5 Announced partnership with CrossLink Life Sciences, LLC to expand ZYNRELEF promotional efforts on January 7, 2024; January 23, 2024 label expansion 3 Vial Access Needle (VAN) and Prefilled Syringe (PFS) are all budgeted and making progress 3 months ended December ...
Heron Therapeutics(HRTX) - 2023 Q4 - Earnings Call Transcript
2024-03-13 02:35
Financial Data and Key Metrics - ZYNRELEF achieved a record net revenue of $5.6 million in Q4 2023, marking the first time it surpassed $5 million in a quarter [16] - The oncology franchise outperformed expectations with CINVANTI net revenues of $94.9 million and SUSTOL net revenues of $13 million for the year [25] - Total acute care net revenues for the year were $19.1 million, including APONVIE net revenues of $1.4 million [55] - Gross margins improved to over 70% due to better inventory management and renegotiations with manufacturers, with future margins expected to reach the mid-70s range [24] - The company closed 2023 with over $80 million in cash and cash equivalents, sufficient to reach profitability by Q4 2024 [24] Business Line Performance - The acute care franchise, particularly ZYNRELEF, is expected to drive the majority of product growth, with significant momentum anticipated in 2025 following the launch of VAN and full training of new sales representatives [17] - The oncology franchise continues to show consistent performance, with CINVANTI and SUSTOL expected to maintain their strong performance [25] - APONVIE is positioned to address postoperative nausea and vomiting, a significant unmet need, with high-risk patients experiencing rates as high as 80% [20] Market Performance - The CrossLink partnership, signed in January 2024, is expected to significantly impact ZYNRELEF revenues, with over 150 sales representatives trained and ready by the end of 2024, and an additional 650 reps to be fully trained nationwide [26] - The ASC (Ambulatory Surgical Center) segment presents a significant opportunity for cross-selling ZYNRELEF and APONVIE, particularly in the orthopedic space [56] Strategic Direction and Industry Competition - The company has implemented cost reduction strategies, including headcount reductions and streamlining financial processes, leading to a decrease in operational expenses from $182 million in 2022 to $135 million in 2023 [53] - The label expansion for ZYNRELEF, approved by the FDA in January 2024, has doubled the number of indicated procedures, positioning it as a foundational element for postoperative analgesia [32] - The NOPAIN Act, effective from January 2025, will provide reimbursement for non-opioid products in outpatient surgical settings, further supporting the adoption of ZYNRELEF [33] Management Commentary on Operating Environment and Future Outlook - Management anticipates positive EBITDA by Q4 2024 and does not expect to raise additional capital, given the strong balance sheet and operational plan [70] - The company expects ZYNRELEF to see an inflection point in 2025, driven by the launch of VAN and the full impact of the CrossLink partnership [17] - The updated guidelines on postoperative nausea and vomiting prevention in 2024 are expected to enhance awareness and adoption of APONVIE [31] Other Important Information - The VAN (Vial Access Needle) project is progressing well, with expected approval by the end of 2024, and the Prefilled Syringe (PFS) is expected to be approved in 2026 [15] - The company has reduced SG&A expenses from $119.9 million in 2022 to $116.7 million in 2023, with further reductions anticipated [37] Q&A Session Summary Question: Impact of the NOPAIN Act on ZYNRELEF - The NOPAIN Act will provide reimbursement for ZYNRELEF in hospital outpatient departments and ASCs through 2027, with potential extension to 2030, ensuring broader adoption [74] Question: Cost Reduction Plans for 2024 - The company expects operating expenses to stabilize between $108 million to $160 million in 2024, with no significant further cost reductions anticipated [81] Question: Growth Expectations for ZYNRELEF in 2024 - Management remains comfortable with the 50% year-over-year growth projection for acute care products in 2024, driven by the CrossLink partnership and label expansion [76] Question: Opportunity in the ASC Segment - The ASC segment offers significant growth potential, particularly for ZYNRELEF and APONVIE, as the company focuses on the orthopedic space and aligns with ASC goals of rapid patient recovery [78]
Heron Therapeutics(HRTX) - 2023 Q4 - Annual Report
2024-03-12 20:15
Financial Performance - For the year ended December 31, 2023, net product sales were $127.0 million, an increase of 17.9% compared to $107.7 million for the same period in 2022[315]. - Net product sales of ZYNRELEF for the year ended December 31, 2023, were $17.7 million, up from $10.2 million in 2022, reflecting an increase in units sold[316]. - Net product sales of CINVANTI for the year ended December 31, 2023, were $94.9 million, compared to $87.3 million in 2022, primarily due to an increase in units sold[317]. - APONVIE generated net product sales of $1.4 million in 2023, having become commercially available in March 2023[316]. - Net product sales of SUSTOL for the year ended December 31, 2023, were $13.0 million, compared to $10.2 million in 2022, attributed to an increase in units sold[317]. Cost and Expenses - Cost of product sales for the year ended December 31, 2023, was $65.1 million, an increase from $54.9 million in 2022, driven by higher inventory write-offs[318]. - The cost of product sales included charges of $20.3 million in 2023 and $8.9 million in 2022, primarily from the write-off of ZYNRELEF inventory[318]. - The increase in cost of product sales was partially offset by a decrease in cost per unit for CINVANTI and ZYNRELEF due to validated large-scale manufacturing[318]. - For the year ended December 31, 2023, total research and development expense was $55.9 million, a decrease of 48% from $107.5 million in 2022, primarily due to reduced costs related to ZYNRELEF and CINVANTI[320]. - General and administrative expense increased to $49.0 million in 2023 from $37.4 million in 2022, mainly due to severance and stock-based compensation expenses related to executive departures[321]. - Sales and marketing expense decreased to $67.6 million in 2023, down 18% from $82.5 million in 2022, attributed to improved operational efficiencies in the commercialization of ZYNRELEF[322]. Net Loss and Cash Flow - The net loss for the year ended December 31, 2023, was $110.6 million, or $0.80 per share, compared to a net loss of $182.0 million, or $1.67 per share, for the same period in 2022[326]. - Net cash used in operating activities decreased to $58.8 million in 2023 from $146.9 million in 2022, primarily due to lower operating expenses and changes in working capital[326]. - As of December 31, 2023, the company had cash, cash equivalents, and short-term investments totaling $80.4 million, sufficient to meet anticipated cash requirements for at least one year[325]. - Net cash provided by investing activities was $18.0 million in 2023, compared to net cash used of $3.3 million in 2022, primarily due to net maturities of short-term investments[327]. Obligations and Agreements - The company had total purchase obligations of $60.2 million as of December 31, 2023, with $39.0 million due in one year and $21.2 million due within two to three years[331]. - As of December 31, 2023, $150.0 million of convertible notes were outstanding, maturing on May 26, 2026[332]. - The company entered into a sublease agreement for 5,840 square feet of office space in Cary, North Carolina, with a lease term expiring on April 30, 2025[330]. Future Outlook - The company expects total operating expenses to decrease year-over-year in 2024 due to cost reduction efforts[298]. - The company continues to monitor factors impacting its business and does not believe they are material as of the filing date of the report[298].
Heron Therapeutics(HRTX) - 2023 Q4 - Annual Results
2024-03-12 20:10
EXHIBIT 99.1 Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Updates SAN DIEGO, March 12, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and twelve months ended December 31, 2023 and highlighted recent corporate updates. | Product Revenues, Net | $138.0 to $158.0 million | | --- | --- | | Adjusted Operating Expens ...
Heron Therapeutics(HRTX) - 2023 Q3 - Quarterly Report
2023-11-14 21:15
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, 2023 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 4242 Campus Point Court, Suite 200 San Diego, CA 92121 (Address of principal executive offices) (Zip Code) Reg ...
Heron Therapeutics(HRTX) - 2023 Q2 - Earnings Call Transcript
2023-08-14 22:48
Heron Therapeutics, Inc. (NASDAQ:HRTX) Q2 2023 Earnings Conference Call August 14, 2023 4:30 PM ET Company Participants Jeff Cohen - Executive Director, Assistant General Counsel and Assistant Secretary Craig Collard - Chief Executive Officer Ira Duarte - Executive Vice President and Chief Financial Officer Bill Forbes - Executive Vice President and Chief Development Officer Conference Call Participants Serge Belanger - Needham & Company Boris Peaker - TD Cowen Carl Byrnes - Northland Capital Markets Operat ...
Heron Therapeutics(HRTX) - 2023 Q2 - Quarterly Report
2023-08-14 20:16
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, 2023 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 jurisdicti ...
Heron Therapeutics(HRTX) - 2023 Q1 - Earnings Call Transcript
2023-05-12 02:18
Heron Therapeutics, Inc. (NASDAQ:HRTX) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Craig Collard - Chief Executive Officer David Szekeres - Executive Vice President & Chief Operating Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Rohit Bhasin - Needham & Company Carl Byrnes - Northland Operator Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q1 2023 Earnings Conference. Before we begin, I would like t ...
Heron Therapeutics(HRTX) - 2023 Q1 - Quarterly Report
2023-05-11 20:11
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 March 31, 2023 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 jurisdict ...
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].