Heron Therapeutics(HRTX)

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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
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Condensed%20Consolidated%20Financial%20Statements) The company reported total assets of **$229.2 million** and a total stockholders' deficit of **$27.8 million** as of September 30, 2023, with improved sales and reduced net loss for the nine-month period [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets decreased to **$229.2 million**, total liabilities increased to **$257.0 million**, resulting in a shift from stockholders' equity to a **$27.8 million** deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $34,859 | $15,364 | | Short-term investments | $42,553 | $69,488 | | Total current assets | $193,979 | $205,435 | | Total assets | $229,199 | $250,951 | | Total current liabilities | $79,745 | $82,355 | | Non-current notes payable, net | $24,023 | $0 | | Total liabilities | $256,985 | $237,379 | | Total stockholders' equity (deficit) | ($27,786) | $13,572 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net product sales increased to **$92.8 million** for the nine months ended September 30, 2023, while net loss significantly narrowed to **$99.8 million** due to higher gross profit and reduced operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $31,434 | $26,557 | $92,811 | $77,644 | | Gross profit | $13,226 | $11,840 | $37,591 | $35,397 | | Total operating expenses | $38,155 | $53,722 | $137,986 | $189,700 | | Loss from operations | ($24,929) | ($41,882) | ($100,395) | ($154,303) | | Net loss | ($25,008) | ($41,908) | ($99,835) | ($162,155) | | Basic and diluted net loss per share | ($0.17) | ($0.38) | ($0.75) | ($1.54) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$61.2 million** for the nine months ended September 30, 2023, with financing activities providing **$53.9 million**, leading to a **$19.5 million** net increase in cash Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($61,244) | ($109,378) | | Net cash provided by (used in) investing activities | $26,831 | ($5,345) | | Net cash provided by financing activities | $53,908 | $74,620 | | Net increase (decrease) in cash and cash equivalents | $19,495 | ($40,103) | | Cash and cash equivalents at end of period | $34,859 | $50,438 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Key notes include **99%** revenue concentration from three customers, **$20.3 million** ZYNRELEF inventory write-offs, **$17.3 million** in restructuring costs, and new financing from a **$50 million** facility and **$29.8 million** private placement - The company is a commercial-stage biotechnology firm with four approved products: ZYNRELEF, APONVIE, CINVANTI, and SUSTOL, and management believes current cash, cash equivalents, and short-term investments of **$77.4 million** are sufficient to fund operations for at least one year[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - The company has a significant concentration of credit risk, with three major customers accounting for **99.0%** of product sales and **99.7%** of accounts receivable for the nine months ended September 30, 2023[33](index=33&type=chunk)[34](index=34&type=chunk) - Cost of product sales for the nine months ended September 30, 2023 included **$20.3 million** in charges for the write-off of ZYNRELEF inventory, compared to **$4.5 million** in the same period in 2022[59](index=59&type=chunk) - In 2023, the company incurred **$3.9 million** in costs for a restructuring plan and an additional **$13.4 million** in expenses related to the departure of five executive officers, primarily for severance and stock-based compensation[64](index=64&type=chunk)[66](index=66&type=chunk) - In August 2023, the company entered into a **$50.0 million** working capital facility agreement, drawing an initial **$25.0 million**, and in July 2023, it raised net proceeds of **$29.8 million** from a private placement of common stock and warrants[69](index=69&type=chunk)[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **19.6%** sales growth to **$92.8 million** for the first nine months of 2023, a narrowed net loss due to reduced operating expenses, and new financing ensuring sufficient capital for at least one year [Overview of Product Portfolio](index=22&type=section&id=Overview%20of%20Product%20Portfolio) The company's portfolio includes ZYNRELEF, APONVIE, CINVANTI, and SUSTOL, with a pending sNDA for ZYNRELEF, the recent launch of APONVIE, validated large-scale manufacturing, and a paused HTX-034 development - An sNDA to expand ZYNRELEF's indication to broadly cover soft tissue and orthopedic surgical procedures is under FDA review, with a PDUFA goal date extended to **January 23, 2024**[99](index=99&type=chunk) - APONVIE, for prevention of postoperative nausea and vomiting (PONV), was commercially launched in the U.S. in **March 2023** and received CMS pass-through payment status effective **April 1, 2023**[104](index=104&type=chunk) - The company has validated larger-scale manufacturing for both CINVANTI and ZYNRELEF, which is expected to significantly reduce the cost of product sales[100](index=100&type=chunk)[117](index=117&type=chunk) - Development of HTX-034, a next-generation product candidate for postoperative pain, has been paused to evaluate the program and market potential[23](index=23&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Net product sales increased **19.6%** to **$92.8 million** for the nine months ended September 30, 2023, while R&D and Sales & Marketing expenses significantly decreased, and G&A expense rose due to severance costs Net Product Sales by Product (in millions) | Product | YTD 2023 | YTD 2022 | % Change | | :--- | :--- | :--- | :--- | | CINVANTI | $70.6 | $64.2 | +10.0% | | ZYNRELEF | $12.0 | $6.3 | +90.5% | | SUSTOL | $9.3 | $7.1 | +31.0% | | APONVIE | $0.9 | $0.0 | N/A | | **Total** | **$92.8** | **$77.6** | **+19.6%** | Operating Expenses (in millions) | Expense Category | YTD 2023 | YTD 2022 | % Change | | :--- | :--- | :--- | :--- | | Research and Development | $44.9 | $96.4 | -53.4% | | General and Administrative | $37.7 | $28.5 | +32.3% | | Sales and Marketing | $55.3 | $64.7 | -14.5% | - The decrease in R&D expense was primarily due to the completion of production scale-up, validation activities, and raw materials qualification for ZYNRELEF and CINVANTI in 2022[128](index=128&type=chunk) - The increase in G&A expense was primarily due to severance and non-cash, stock-based compensation expense related to executive departures in 2023, along with ongoing legal costs for CINVANTI patent litigation[129](index=129&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$77.4 million** in cash and investments, affirming sufficient liquidity for at least one year, bolstered by **$53.9 million** in financing activities and improved operating cash flow - The company had cash, cash equivalents and short-term investments of **$77.4 million** as of **September 30, 2023**[133](index=133&type=chunk) - Management believes that existing cash, cash equivalents, and short-term investments will be sufficient to meet anticipated cash requirements for at least one year from the filing date of the 10-Q[133](index=133&type=chunk) - In August 2023, the company secured a working capital facility of up to **$50.0 million** and drew down the initial **$25.0 million** tranche[139](index=139&type=chunk) - Net cash used in operating activities for the nine months ended September 30, 2023, decreased to **$61.2 million** from **$109.4 million** in the same period in 2022, primarily due to a lower net loss[135](index=135&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This disclosure is not required for smaller reporting companies - Disclosure is not required for smaller reporting companies[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective at the reasonable assurance level as of **September 30, 2023**[145](index=145&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is engaged in patent infringement litigation against Fresenius Kabi and Mylan to defend its CINVANTI patents, resulting in FDA approval stays for generic versions until **late 2024** and **early 2026** - Heron filed a patent infringement complaint against Fresenius Kabi in **July 2022** after Fresenius Kabi sought FDA approval for a generic version of CINVANTI, with a five-day bench trial scheduled for **June 24, 2024**[148](index=148&type=chunk)[149](index=149&type=chunk) - Heron filed a similar patent infringement complaint against Mylan in **September 2023** after Mylan also sought approval for a generic CINVANTI[150](index=150&type=chunk) - As a result of the lawsuits, the FDA is stayed from approving Fresenius's ANDA until **December 14, 2024**, and Mylan's ANDA until **February 4, 2026**, or until the respective litigations are resolved[149](index=149&type=chunk)[150](index=150&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes have occurred from the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended **December 31, 2022** - There have been no material changes from the risk factors disclosed in the Annual Report on Form 10-K for the year ended **December 31, 2022**[151](index=151&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[153](index=153&type=chunk) [Item 6. Exhibits](index=31&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including the **July 2023** Securities Purchase Agreement, **August 2023** Working Capital Facility Agreement, and Sarbanes-Oxley Act certifications - Exhibits filed include the **July 2023** Securities Purchase Agreement, the **August 2023** Working Capital Facility Agreement, and Sarbanes-Oxley Act certifications[157](index=157&type=chunk)
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
Financial Data and Key Metrics Changes - Total product net revenues for Q1 2023 were $29.6 million, an increase of over 26% from $23.5 million in Q1 2022 [5][24] - ZYNRELEF net product sales were $3.5 million for Q1 2023, while APONVIE net product sales were $244,000 since its launch in March 2023 [19] - Cost of product sales for Q1 2023 was $16.9 million, compared to $11.4 million in Q1 2022, including a one-time charge of $5.3 million for short-dated ZYNRELEF inventory [20] - Research and development expenses decreased from $42.1 million in Q1 2022 to $13.8 million in Q1 2023 [26] - The company reported a loss from operations of $33.1 million for Q1 2023, an improvement from a loss of $62.9 million in Q1 2022 [27] Business Line Data and Key Metrics Changes - The Oncology Care franchise net product sales for Q1 2023 were $25.8 million, representing a 15% increase over the same quarter in the prior year [25] - The company expects Oncology Care franchise net product sales for the full year 2023 to be between $99 million and $103 million [25] Company Strategy and Development Direction - The new CEO emphasized the need for a thorough internal review to develop a long-term plan aimed at maximizing shareholder value [13] - Changes will include reducing cash burn, improving operational efficiency, and implementing a realistic product forecast [14] - A flattening of the executive reporting structure has been initiated to enhance sales and marketing efforts [15] Management's Comments on Operating Environment and Future Outlook - The management acknowledged challenges with ZYNRELEF's uptake and indicated that training and preparation are essential for successful product application [9][10] - The CEO expressed optimism about APONVIE's potential, highlighting its favorable clinical profile and market opportunities [11] - The management is committed to providing updates on strategic changes and believes these will position the company for long-term success [18] Other Important Information - The company is exploring enhancements to product handling, including a vial access needle and a prefilled syringe, which could significantly improve usability [7][10] - The management is assessing the alignment of the sales force to optimize resources between ZYNRELEF and APONVIE [40][52] Q&A Session Summary Question: What are the specifics to change the trajectory of ZYNRELEF? - The CEO mentioned the importance of optimizing resources and improving product training to enhance sales [31][34] Question: How is APONVIE being marketed moving forward? - The CEO indicated that resources may shift towards APONVIE due to its easier market entry compared to ZYNRELEF [40] Question: Will the previous guidance for the CINV franchise still stand? - The CEO confirmed that the CINV franchise is progressing steadily but prefers to provide guidance from a company-wide perspective in the future [50] Question: Are there plans to reduce the sales force? - The CEO stated that while efficiency is a goal, any changes would focus on realignment rather than outright reductions, especially on the oncology side [52] Question: What is the expected gross profit margin moving forward? - The CEO expressed a goal of achieving gross margins around 80% by reducing costs of goods sold [57]
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].
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]