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): February 26, 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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100 Regency Forest Drive, Suite 300, Cary, NC |
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27518 |
(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 February 26, 2026, Heron Therapeutics, Inc. issued a press release announcing its financial results for the three and twelve months ended December 31, 2025 (“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 February 26, 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: February 26, 2026 |
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/s/ Ira Duarte |
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Ira Duarte Executive Vice President, Chief Financial Officer |
Heron Therapeutics Announces Fourth Quarter and Full-Year 2025 Financial Results
-ZYNRELEF® and APONVIE® Drive 65% Year-Over-Year Net Revenue Growth in Acute Care Franchise
-Achieved $154.9 Million in 2025 Net Revenue
-Issues Full-Year 2026 Net Revenue Guidance of $173 to $183 Million and Adjusted EBITDA of $10 to $20 Million
CARY, N.C., February 26, 2026 (GLOBE NEWSWIRE) -- 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, 2025, and highlighted recent corporate updates.
“As demonstrated in today’s release, we are entering 2026 with exceptional momentum. The fourth quarter delivered the strongest results in the history of Heron’s Acute Care franchise, underscoring the success of the strategic decisions we implemented to unlock the full potential of these assets,” said Craig Collard, Chief Executive Officer of Heron. “The milestones achieved in 2025, particularly for ZYNRELEF - including enhanced distributor‑partner incentives, the seamless completion of the Vial Access Needle transition, and CMS approval of a product‑specific J‑Code - are already accelerating adoption and strengthening our competitive position in a large and underpenetrated market.”
“With a more powerful commercial engine, expanding demand signals, and improved reimbursement clarity, we believe Heron is well‑positioned for continued share gains and meaningful revenue expansion in 2026 and beyond.”
Financial Guidance for 2026
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2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions) |
Net Revenue |
$173 to $183 million |
Adjusted EBITDA |
$10 to $20 million |
Business Highlights
-Heron’s Acute Care franchise delivered revenue growth of 57.3% year-over-year in Q4 2025 and 65.1% year-over-year for 2025 compared to 2024, reflecting continued commercial acceleration.
oThe permanent, product specific J-Code (J0668) for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services (“CMS”), was approved effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care.
oTransition to the Vial Access Needle is complete, optimizing product preparation, handling, and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across the U.S.
oThrough aligned partnerships with leading distributors, we are broadening account access and elevating education around ZYNRELEF’s differentiated clinical profile, driving durable surgeon adoption and expansion of use.
oDevelopment of the proposed Prefilled Syringe market presentation is progressing and, if successful, FDA approval is anticipated in mid-to-late 2027.
oInclusion of APONVIE (aprepitant) Injectable Emulsion in the Newly Released Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting (“PONV”), highlighting the clinical impact of aprepitant, use of multimodal PONV prophylaxis, and expanding recognition of the need for long-acting antiemetic coverage.
oCMS has granted a permanent, product specific J-Code (J8502) for APONVIE.
oFully dedicated sales team, launched in Q3 2025, is gaining significant momentum in both expanding formulary access and driving successful utilization of APONVIE.
oThe Oncology franchise continues to deliver a strong revenue base, generating over $105 million in 2025 net revenue despite complex market dynamics.
-Cash, cash equivalents, and short-term investments were $46.6 million as of December 31, 2025.
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Net Revenue Performance – Twelve Months Ended December 31 (in thousands) |
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2025 |
2024 |
Dollar Change |
Percentage Change |
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Acute Care |
$ 49,643 |
$ 30,064 |
$ 19,579 |
65.1% |
APONVIE |
$ 11,571 |
$ 4,518 |
$ 7,053 |
156.1% |
ZYNRELEF |
$ 38,072 |
$ 25,546 |
$ 12,526 |
49.0% |
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Oncology |
$ 105,261 |
$ 114,221 |
$ (8,960) |
(7.8%) |
CINVANTI |
$ 96,758 |
$ 100,079 |
$ (3,321) |
(3.3%) |
SUSTOL |
$ 8,503 |
$ 14,142 |
$ (5,639) |
(39.9%) |
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Total Net Revenue |
$ 154,904 |
$ 144,285 |
$ 10,619 |
7.4% |
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Net Revenue Performance – Three Months Ended December 31 (in thousands) (unaudited) |
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2025 |
2024 |
Dollar Change |
Percentage Change |
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Acute Care |
$ 16,344 |
$ 10,389 |
$ 5,955 |
57.3% |
APONVIE |
$ 3,814 |
$ 1,932 |
$ 1,882 |
97.4% |
ZYNRELEF |
$ 12,530 |
$ 8,457 |
$ 4,073 |
48.2% |
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Oncology |
$ 24,244 |
$ 30,392 |
$ (6,148) |
(20.2%) |
CINVANTI |
$ 22,917 |
$ 26,873 |
$ (3,956) |
(14.7%) |
SUSTOL |
$ 1,328 |
$ 3,519 |
$ (2,191) |
(62.3%) |
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Total Net Revenue |
$ 40,588 |
$ 40,781 |
$ (193) |
(0.5%) |
Conference Call and Webcast
Heron will host a conference call and live webcast on Thursday, February 26, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron's website for sixty days following the call.
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”) Prevention
APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative 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.
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, provide 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 potential market opportunities for ZYNRELEF®, APONVIE®, CINVANTI® and SUSTOL®; revenue, adjusted EBITDA and other financial guidance provided by the Company; interim financial data or prescription data, which may not necessarily be indicative of quarterly or annual results; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; 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 and the settlement described herein; 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 and the risk that future equity financings may be needed;; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions. 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)
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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(Unaudited) |
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Net product sales |
$ |
40,588 |
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$ |
40,781 |
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$ |
154,904 |
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$ |
144,285 |
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Cost of product sales |
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11,119 |
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10,229 |
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41,347 |
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38,648 |
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Gross profit |
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29,469 |
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30,552 |
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113,557 |
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105,637 |
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Operating expenses: |
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Research and development |
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3,746 |
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3,178 |
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12,429 |
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16,683 |
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General and administrative |
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13,452 |
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12,144 |
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54,605 |
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53,397 |
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Sales and marketing |
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12,233 |
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11,057 |
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49,061 |
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47,085 |
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Total operating expenses |
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29,431 |
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26,379 |
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116,095 |
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117,165 |
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Income (Loss) from operations |
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38 |
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4,173 |
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(2,538) |
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(11,528) |
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Loss on debt extinguishment |
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- |
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- |
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(11,339) |
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- |
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Other expense, net |
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(2,992) |
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(510) |
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(6,318) |
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(2,052) |
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Net loss |
$ |
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(2,954) |
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$ |
3,663 |
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$ |
(20,195) |
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$ |
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(13,580) |
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Basic and diluted net loss per share |
$ |
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(0.02) |
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$ |
0.02 |
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$ |
(0.12) |
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$ |
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(0.09) |
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Weighted average common shares outstanding, basic and diluted |
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188,031 |
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153,151 |
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166,707 |
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152,449 |
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Heron Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands)
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December 31,
2025 |
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December 31,
2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ 28,647 |
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$ 25,802 |
Short-term investments |
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17,984 |
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33,481 |
Accounts receivable, net |
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89,587 |
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78,881 |
Inventory, net |
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92,746 |
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53,160 |
Prepaid expenses and other current assets |
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9,102 |
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17,690 |
Total current assets |
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238,066 |
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209,014 |
Property and equipment, net |
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12,403 |
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14,863 |
Right-of-use lease assets |
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— |
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2,787 |
Other assets |
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5,408 |
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6,483 |
Total assets |
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$ 255,877 |
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$ 233,147 |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
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$ 8,994 |
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$ 11,709 |
Accrued clinical and manufacturing liabilities |
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26,597 |
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25,402 |
Accrued payroll and employee liabilities |
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9,270 |
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9,554 |
Other accrued liabilities |
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51,237 |
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41,755 |
Current lease liabilities |
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— |
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3,037 |
Total current liabilities |
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96,098 |
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91,457 |
Non-current notes payable, net |
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107,899 |
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25,026 |
Non-current convertible notes payable, net |
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32,739 |
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149,700 |
Other non-current liabilities |
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4,808 |
|
615 |
Total liabilities |
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241,544 |
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266,798 |
Commitments and contingencies (see Note 6) |
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Stockholders’ deficit: |
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Common stock |
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1,883 |
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1,521 |
Series A convertible preferred stock |
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1,050 |
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— |
Additional paid-in capital |
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1,951,185 |
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1,884,409 |
Accumulated other comprehensive income |
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4 |
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13 |
Accumulated deficit |
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(1,939,789) |
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(1,919,594) |
Total stockholders’ equity (deficit) |
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14,333 |
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(33,651) |
Total liabilities and stockholders’ equity (deficit) |
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$ 255,877 |
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$ 233,147 |
Heron Therapeutics, Inc.
U.S. GAAP to Non-GAAP Reconciliation
Adjusted EBITDA
(unaudited)
(in thousands)
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Twelve Months Ended December 31, |
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2025 |
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2024 |
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Net loss |
$ |
(20,195) |
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$ |
(13,580) |
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Other expense, net |
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17,657 |
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2,052 |
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Inventory reserve and write-offs |
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4,630 |
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2,474 |
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Depreciation |
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2,314 |
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2,492 |
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Stock-based compensation |
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10,339 |
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12,962 |
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Adjusted EBITDA |
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$ |
14,745 |
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$ |
6,400 |
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Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
