– ZYNRELEF® and APONVIE® Drive 65% Year-Over-Year Net Revenue Growth in Acute Care Franchise
– Achieved
– Issues Full-Year 2026 Net Revenue Guidance of
“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
“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
| Item | 2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions) |
| Net Revenue | |
| Adjusted EBITDA |
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.
– ZYNRELEF Updates:
-
- The permanent, product specific J-Code (J0668) for ZYNRELEF, granted by the
Centers for Medicare and Medicaid Services (“CMS”), was approved effectiveOctober 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care. - Transition 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. - Through 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.
- Development of the proposed Prefilled Syringe market presentation is progressing and, if successful, FDA approval is anticipated in mid-to-late 2027.
- The permanent, product specific J-Code (J0668) for ZYNRELEF, granted by the
– APONVIE Updates:
-
- Inclusion 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.
- CMS has granted a permanent, product specific J-Code (J8502) for APONVIE.
- Fully dedicated sales team, launched in Q3 2025, is gaining significant momentum in both expanding formulary access and driving successful utilization of APONVIE.
- Inclusion 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.
– Oncology Updates:
-
- The Oncology franchise continues to deliver a strong revenue base, generating over
$105 million in 2025 net revenue despite complex market dynamics.
- The Oncology franchise continues to deliver a strong revenue base, generating over
– Cash, cash equivalents, and short-term investments were
| Net Revenue Performance – Twelve Months Ended | |||||
| 2025 | 2024 | Percentage Change | |||
| Acute | $49,643 | $30,064 | $19,579 | 65.1% | |
| APONVIE | 156.1% | ||||
| ZYNRELEF | 49.0% | ||||
| Oncology | $105,261 | $114,221 | $(8,960) | (7.8%) | |
| CINVANTI | (3.3%) | ||||
| SUSTOL | (39.9%) | ||||
| Total Net Revenue | $154,904 | $144,285 | $10,619 | 7.4% | |
| Net Revenue Performance – Three Months Ended (unaudited) | |||||
| 2025 | 2024 | Percentage Change | |||
| Acute | $16,344 | $10,389 | $5,955 | 57.3% | |
| APONVIE | 97.4% | ||||
| ZYNRELEF | 48.2% | ||||
| Oncology | $24,244 | $30,392 | $(6,148) | (20.2%) | |
| CINVANTI | (14.7%) | ||||
| SUSTOL | (62.3%) | ||||
| Total Net Revenue | $40,588 | $40,781 | $(193) | (0.5%) | |
Conference Call and Webcast
Heron will host a conference call and live webcast on
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
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
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
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
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
Consolidated Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended | Twelve Months Ended | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| (Unaudited) | |||||||||||||||||
| Net product sales | $ | 40,588 | $ | 40,781 | $ | 154,904 | $ | 144,285 | |||||||||
| Cost of product sales | 11,119 | 10,229 | 41,347 | 38,648 | |||||||||||||
| Gross profit | 29,469 | 30,552 | 113,557 | 105,637 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 3,746 | 3,178 | 12,429 | 16,683 | |||||||||||||
| General and administrative | 13,452 | 12,144 | 54,605 | 53,397 | |||||||||||||
| Sales and marketing | 12,233 | 11,057 | 49,061 | 47,085 | |||||||||||||
| Total operating expenses | 29,431 | 26,379 | 116,095 | 117,165 | |||||||||||||
| Income (Loss) from operations | 38 | 4,173 | (2,538 | ) | (11,528 | ) | |||||||||||
| Loss on debt extinguishment | - | - | (11,339 | ) | - | ||||||||||||
| Other expense, net | (2,992 | ) | (510 | ) | (6,318 | ) | (2,052 | ) | |||||||||
| Net loss | $ | (2,954 | ) | $ | 3,663 | $ | (20,195 | ) | $ | (13,580 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.02 | ) | $ | 0.02 | $ | (0.12 | ) | $ | (0.09 | ) | ||||||
| Weighted average common shares outstanding, basic and diluted | 188,031 | 153,151 | 166,707 | 152,449 | |||||||||||||
Consolidated Balance Sheets
(in thousands)
2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,647 | $ | 25,802 | ||||
| Short-term investments | 17,984 | 33,481 | ||||||
| Accounts receivable, net | 89,587 | 78,881 | ||||||
| Inventory, net | 92,746 | 53,160 | ||||||
| Prepaid expenses and other current assets | 9,102 | 17,690 | ||||||
| Total current assets | 238,066 | 209,014 | ||||||
| Property and equipment, net | 12,403 | 14,863 | ||||||
| Right-of-use lease assets | — | 2,787 | ||||||
| Other assets | 5,408 | 6,483 | ||||||
| Total assets | $ | 255,877 | $ | 233,147 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,994 | $ | 11,709 | ||||
| Accrued clinical and manufacturing liabilities | 26,597 | 25,402 | ||||||
| Accrued payroll and employee liabilities | 9,270 | 9,554 | ||||||
| Other accrued liabilities | 51,237 | 41,755 | ||||||
| Current lease liabilities | — | 3,037 | ||||||
| Total current liabilities | 96,098 | 91,457 | ||||||
| Non-current notes payable, net | 107,899 | 25,026 | ||||||
| Non-current convertible notes payable, net | 32,739 | 149,700 | ||||||
| Other non-current liabilities | 4,808 | 615 | ||||||
| Total liabilities | 241,544 | 266,798 | ||||||
| Commitments and contingencies (see Note 6) | ||||||||
| Stockholders’ deficit: | ||||||||
| Common stock | 1,883 | 1,521 | ||||||
| Series A convertible preferred stock | 1,050 | — | ||||||
| Additional paid-in capital | 1,951,185 | 1,884,409 | ||||||
| Accumulated other comprehensive income | 4 | 13 | ||||||
| Accumulated deficit | (1,939,789 | ) | (1,919,594 | ) | ||||
| Total stockholders’ equity (deficit) | 14,333 | (33,651 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 255,877 | $ | 233,147 | ||||
Adjusted EBITDA
(unaudited)
(in thousands)
| Twelve Months Ended | ||||||||||
| 2025 | 2024 | |||||||||
| Net loss | $ | (20,195 | ) | $ | (13,580 | ) | ||||
| Other expense, net | 17,657 | 2,052 | ||||||||
| Inventory reserve and write-offs | 4,630 | 2,474 | ||||||||
| Depreciation | 2,314 | 2,492 | ||||||||
| Stock-based compensation | 10,339 | 12,962 | ||||||||
| Adjusted EBITDA | $ | 14,745 | $ | 6,400 | ||||||
Investor Relations and Media Contact:
Executive Vice President, Chief Financial Officer
iduarte@herontx.com
858-251-4400
