UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2026
Heron Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-33221 |
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94-2875566 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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25 Fenton Main Street, Suite 300, Cary, NC |
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27511 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code (858) 251-4400
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.01 per share |
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HRTX |
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The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2026, Heron Therapeutics, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2026 (“Earnings Press Release”). A copy of the Earnings Press Release is furnished as Exhibit 99.1.
The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release, dated November 9, 2026 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Heron Therapeutics, Inc. |
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Date: November 9, 2026 |
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/s/ Ira Duarte |
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Ira Duarte Executive Vice President, Chief Financial Officer |
Exhibit 99.1
Heron Therapeutics Announces Third Quarter 2026 Financial Results
•Q3 2026 net revenue of $35.3 million; ZYNRELEF® net revenue up 13.8% and APONVIE® net revenue up 49.3% compared to the third quarter of 2025
•Entered into a definitive agreement under which CorMedix Therapeutics will acquire substantially all of Heron’s assets, announced separately today
CARY, N.C., November 9, 2026 (GLOBE NEWSWIRE) - Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today announced financial results for the three and nine months ended September 30, 2026 and recent corporate updates.
Business Highlights
•Heron generated total net revenue of $35.3 million in Q3 2026, compared to $38.2 million in Q3 2025 and $37.7 million in Q2 2026. Heron ended the third quarter with $23.4 million in cash, cash equivalents and short-term investments.
•Acute Care franchise updates: Net revenue increased 22.5% year-over-year for the three months ended September 30, 2026 and increased 32.4% year-over-year for the nine months ended September 30, 2026. ZYNRELEF® contributed $10.6 million and $31.9 million net revenue in the three and nine months ended September 30, 2026, respectively. APONVIE® contributed $4.5 million and $12.2 million net revenue in the three and nine months ended September 30, 2026, respectively.
•Oncology Supportive Care franchise updates: Net revenue was $20.1 million in the three months ended September 30, 2026 and $63.5 million in the nine months ended September 30, 2026. CINVANTI® contributed $20.0 million and $62.3 million in the three and nine months ended September 30, 2026, respectively. Commercial sales of SUSTOL® ceased on September 30, 2026.
•Proposed asset sale: In a separate press release issued today, Heron and CorMedix Therapeutics (“CorMedix”) announced that they have entered into a definitive asset purchase agreement under which CorMedix will acquire substantially all of the assets of Heron (the “Asset Sale”). The Asset Sale is subject to approval by Heron’s stockholders and other customary closing conditions. Additional information is available in that press release and in the Current Report on Form 8-K to be filed by Heron with the Securities and Exchange Commission (“SEC”).
Financial Guidance for 2026
As previously announced, the Company withdrew its full-year 2026 financial guidance in August 2026. The Company is not providing financial guidance at this time.
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Net Revenue Performance – Three Months Ended September 30 (in thousands) (unaudited) |
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2026 |
2025 |
Dollar Change |
Percentage Change |
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Acute Care |
$ 15,128 |
$ 12,347 |
$ 2,781 |
22.5% |
APONVIE |
$ 4,530 |
$ 3,034 |
$ 1,496 |
49.3% |
ZYNRELEF |
$ 10,598 |
$ 9,313 |
$ 1,285 |
13.8% |
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Oncology |
$ 20,122 |
$ 25,866 |
($ 5,744) |
(22.2%) |
CINVANTI |
$ 19,970 |
$ 23,955 |
($ 3,985) |
(16.6%) |
SUSTOL |
$ 152 |
$ 1,911 |
($ 1,759) |
(92.0%) |
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Total Net Revenue |
$ 35,250 |
$ 38,213 |
($ 2,963) |
(7.8%) |
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Net Revenue Performance – Nine Months Ended September 30 (in thousands) (unaudited) |
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2026 |
2025 |
Dollar Change |
Percentage Change |
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Acute Care |
$ 44,088 |
$ 33,300 |
$ 10,788 |
32.4% |
APONVIE |
$ 12,200 |
$ 7,758 |
$ 4,442 |
57.3% |
ZYNRELEF |
$ 31,888 |
$ 25,542 |
$ 6,346 |
24.8% |
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Oncology |
$ 63,539 |
$ 81,016 |
($ 17,477) |
(21.6%) |
CINVANTI |
$ 62,298 |
$ 73,841 |
($ 11,543) |
(15.6%) |
SUSTOL |
$ 1,241 |
$ 7,175 |
($ 5,934) |
(82.7%) |
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Total Net Revenue |
$ 107,627 |
$ 114,316 |
($ 6,689) |
(5.9%) |
Conference Call and Webcast
Heron will not host a conference call or webcast in connection with its third quarter 2026 financial results.
About ZYNRELEF® for Postoperative Pain
ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About APONVIE® for Prevention of Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.
Please see full prescribing information at www.APONVIE.com.
About CINVANTI® for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL® for CINV Prevention
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an
extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
Commercial sales of SUSTOL® ceased on September 30, 2026.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP, provides analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting.
In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but that we do not believe are indicative of ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.
There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments.
For a reconciliation of such non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with GAAP, please see the table titled “U.S. GAAP to Non-GAAP Reconciliation” below.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this news release other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy as well as plans and objectives of management for future operations, are forward-looking statements. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the proposed Asset Sale, including the expected timing of closing; the satisfaction of the conditions to closing the Asset Sale, including approval by Heron's stockholders, on a timely basis or at all; including approval by Heron’s stockholders, and Heron’s plans and expectations following the closing; the commercial potential of ZYNRELEF®, APONVIE®, CINVANTI® and SUSTOL® ; interim financial data or prescription data, which may not necessarily be indicative of quarterly or annual results; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network, LLC; the outcome of the Company’s pending patent litigations, including potential appeals of any verdicts; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron’s cash, cash equivalents and short-term investments; the expected duration over which Heron’s cash, cash equivalents and short-term investments balances will fund its operations; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions; our ability to continue as a going concern without additional funding; the ability of our common stock to meet the minimum requirements for continued listing on the Nasdaq Capital Market; and our ability to comply with covenants in our Working Capital Facility Agreement pending the closing of the Asset Sale and the consequences of any failure to do so. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption “Risk Factors.” Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Heron Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
Net product sales |
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$ 35,250 |
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$ 38,213 |
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$ 107,627 |
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$ 114,316 |
Cost of product sales |
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8,958 |
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11,914 |
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31,168 |
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30,228 |
Gross profit |
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26,292 |
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26,299 |
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76,459 |
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84,088 |
Operating expenses: |
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Research and development |
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3,099 |
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3,470 |
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8,186 |
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8,683 |
General and administrative |
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12,341 |
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13,980 |
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35,762 |
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41,153 |
Sales and marketing |
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12,521 |
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12,942 |
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40,989 |
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36,828 |
Total operating expenses |
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27,961 |
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30,392 |
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84,937 |
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86,664 |
Loss from operations |
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(1,669) |
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(4,093) |
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(8,478) |
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(2,576) |
Loss on debt extinguishment |
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— |
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(11,339) |
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— |
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(11,339) |
Other expense, net |
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(3,337) |
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(2,063) |
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(10,128) |
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(3,326) |
Net loss |
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(5,006) |
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(17,495) |
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(18,606) |
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(17,241) |
Other comprehensive loss: |
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Unrealized (loss) gain on short-term investments |
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(1) |
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1 |
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(11) |
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(13) |
Comprehensive loss |
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$ (5,007) |
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$ (17,494) |
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$ (18,617) |
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$ (17,254) |
Basic net loss per share |
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$ (0.03) |
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$ (0.10) |
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$ (0.10) |
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$ (0.11) |
Diluted net loss per share |
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$ (0.03) |
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$ (0.10) |
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$ (0.10) |
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$ (0.11) |
Weighted average common shares outstanding, basic and diluted |
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190,919 |
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170,348 |
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190,305 |
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159,524 |
Heron Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands)
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September 30,
2026 |
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December 31,
2025 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ 11,595 |
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$ 28,647 |
Short-term investments |
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11,854 |
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17,984 |
Accounts receivable, net |
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86,735 |
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89,587 |
Inventory, net |
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91,301 |
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92,746 |
Prepaid expenses and other current assets |
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7,627 |
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9,102 |
Total current assets |
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209,112 |
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238,066 |
Property and equipment, net |
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11,081 |
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12,403 |
Right-of-use lease asset |
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5,448 |
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— |
Other assets |
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4,807 |
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5,408 |
Total assets |
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$ 230,448 |
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$ 255,877 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ 8,375 |
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$ 8,994 |
Accrued clinical and manufacturing liabilities |
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20,106 |
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26,597 |
Accrued payroll and employee liabilities |
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8,836 |
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9,270 |
Other accrued liabilities |
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52,172 |
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51,237 |
Current lease liability |
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359 |
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— |
Total current liabilities |
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89,848 |
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96,098 |
Non-current notes payable, net |
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91,634 |
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107,899 |
Non-current convertible notes payable, net |
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34,377 |
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32,739 |
Non-current lease liability |
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5,359 |
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— |
Other non-current liabilities |
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4,314 |
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4,808 |
Total liabilities |
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225,532 |
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241,544 |
Stockholders' equity: |
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Common stock |
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1,900 |
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1,883 |
Series A convertible preferred stock |
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1,050 |
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1,050 |
Additional paid-in capital |
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1,960,368 |
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1,951,185 |
Accumulated other comprehensive (loss) income |
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(7) |
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4 |
Accumulated deficit |
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(1,958,395) |
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(1,939,789) |
Total stockholders' equity |
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4,916 |
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14,333 |
Total liabilities and stockholders' equity |
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$ 230,448 |
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$ 255,877 |
Heron Therapeutics, Inc.
U.S. GAAP to Non-GAAP Reconciliation
Adjusted EBITDA
(unaudited)
(in thousands)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
Net loss |
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$ |
(5,006) |
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$ |
(17,495) |
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$ |
(18,606) |
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$ |
(17,241) |
Other expense, net |
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3,337 |
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13,402 |
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10,128 |
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14,665 |
Inventory reserve and write-offs |
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454 |
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2,169 |
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1,738 |
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2,169 |
Project related legal expenses |
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1,441 |
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- |
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2,355 |
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- |
Depreciation and amortization |
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391 |
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614 |
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1,372 |
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1,777 |
Stock-based compensation |
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3,083 |
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2,852 |
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9,237 |
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|
8,160 |
Adjusted EBITDA |
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$ |
3,700 |
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$ |
1,542 |
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$ |
6,224 |
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$ |
9,530 |
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
