- Q1 2026 net revenue growth year-over year for Acute Care franchise (+32%), including ZYNRELEF® (+27%) and APONVIE® (+50%)
- Q1 2026 total net revenue of
$34.7 million - Reached settlement with
Baxter Healthcare Corporation in CINVANTI® patent litigation - Reaffirmed 2026 full-year guidance of $173–$183 million net revenue; $10–$20 million Adjusted EBITDA
“Despite typical first-quarter seasonality and unusual weather-related disruption early in the quarter, we saw a clear recovery in February and March,” said
“As environmental conditions normalized, we saw momentum rebuild through February and exited March with improved trends. We maintained disciplined cost management and expect temporary gross margin pressure to normalize as we work through higher-cost CINVANTI® inventory over the next two quarters,” said
Business Highlights
- Heron generated total net revenue of
$34.7 million in Q1 2026 and ended the first quarter with$44.8 million in cash, cash equivalents and short-term investments. The Company reaffirmed full-year 2026 guidance of net revenue of$173 million to$183 million and Adjusted EBITDA of$10 million to$20 million .
- Acute Care franchise updates: Net revenue increased 32% year-over-year, including ZYNRELEF® net revenue of
$10.2 million and APONVIE® net revenue of$3.4 million in Q1 2026.
- Commercial expansion: Heron’s planned sales force expansion remains on track for Q3 2026, with recruitment underway to increase coverage and account depth across the portfolio.
ZYNRELEF:
- Demand units increased by 22% year-over-year. IGNITE, the commercial alignment program for ZYNRELEF, demonstrated 111% growth in target accounts by year-end 2025. This success resulted in expansion of included target accounts in
January 2026 by 40% and extension of the program throughout 2026 with IGNITE 2.0.
- ZYNRELEF continues to benefit from NOPAIN Act reimbursement and an increasingly predictable payment experience among 110 million covered commercial lives as accounts increasingly apply the permanent product-specific J-code (J0668).
APONVIE:
- APONVIE demand units increased 68% year-over-year. Accordingly, a key performance metric, Average Daily Units, in Q1 2026 increased 70% over Q1 2025.
- APONVIE has gained P&T approval in 1,902 accounts totaling 5.8 million medium-to-high PONV risk procedures. Broad adoption of APONVIE continued, with ordering accounts increasing 67% year-over-year.
- APONVIE’s permanent product-specific J-code (J8502) became active
April 1, 2026 , which further streamlines billing and supports broader access as utilization expands.
- Fifth Consensus Guidelines for the Management of PONV included APONVIE as the only FDA-approved intravenous NK-1 antagonist for prevention of PONV in adults and elevated the role of NK-1 antagonists in multimodal prophylaxis strategies.
- Oncology
Supportive Care franchise updates: Net revenue was$21.1 million in Q1 2026, including CINVANTI net revenue of$20.5 million and SUSTOL® net revenue of$0.6 million reflecting the previously communicated wind-down of SUSTOL by the end of 2026.
CINVANTI:
- CINVANTI maintained 25% market share in the NK1 CINV category in Q1 2026, equivalent to the average of 25% for the past 12 months.
- The REIGNITE program, with a goal of returning CINVANTI to steady growth, secured formulary wins and the near-term pipeline represents an increase of approximately
$10 million net revenue on an annual basis in potential new opportunity.
- Heron reached a settlement agreement with
Baxter Healthcare Corporation in CINVANTI patent litigation, and theU.S. District Court for the District of Delaware dismissed the pending litigation between the parties onApril 28, 2026 .
- Active promotion of CINVANTI as part of Heron’s planned expansion of its sale force for Q3 2026.
- CINVANTI surpassed 5 million demand units sold since launch
- Development update: The ZYNRELEF prefilled syringe (PFS) lifecycle program
- This late-stage program to improve Operating Room efficiency with a Ready-to-Use product remains funded and on track. As previously announced, registration batches have been manufactured and placed on stability, and the Company will receive 12-month stability data in the first quarter of 2027. Heron is continuing CMC and device-related readiness activities to support the filing.
Financial Guidance for 2026
Item | 2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions) |
| Net Revenue | |
| Adjusted EBITDA |
- Cash, cash equivalents, and short-term investments were
| Net Revenue Performance – Three Months Ended (in thousands) (unaudited) | |||||||||
| 2026 | 2025 | Percentage Change | |||||||
| Acute Care | $ 13,629 | $ 10,302 | $ 3,327 | 32.3 | % | ||||
| APONVIE | 50.2 | % | |||||||
| ZYNRELEF | 27.3 | % | |||||||
| Oncology | $ 21,082 | $ 28,601 | ($7,519) | (26.3 | %) | ||||
| CINVANTI | ( | (20.2 | %) | ||||||
| SUSTOL | ( | (80.9 | %) | ||||||
| Total Net Revenue | $ 34,711 | $ 38,903 | ($4,192) | (10.8 | %) | ||||
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 addition to providing guidance for Net Revenue, a GAAP measure, Heron provides guidance for Adjusted EBITDA, a non-GAAP measure. Heron does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures without unreasonable effort that would be necessary for a reconciliation. These items are uncertain, depend on various factors, and could have a material impact on Heron’s reported results in accordance with GAAP.
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) (unaudited) | |||||||||
| Three Months Ended | |||||||||
| 2026 | 2025 | ||||||||
| Net product sales | $ | 34,711 | $ | 38,903 | |||||
| Cost of product sales | 10,638 | 8,457 | |||||||
| Gross profit | 24,073 | 30,446 | |||||||
| Operating expenses: | |||||||||
| Research and development | 2,385 | 2,279 | |||||||
| General and administrative | 12,145 | 12,702 | |||||||
| Sales and marketing | 14,308 | 12,311 | |||||||
| Total operating expenses | 28,838 | 27,292 | |||||||
| (Loss) income from operations | (4,765 | ) | 3,154 | ||||||
| Other expense, net | (3,346 | ) | (519 | ) | |||||
| Net (loss) income | (8,111 | ) | 2,635 | ||||||
| Other comprehensive (loss) income: | |||||||||
| Unrealized loss on short-term investments | (10 | ) | (12 | ) | |||||
| Comprehensive (loss) income | $ | (8,121 | ) | $ | 2,623 | ||||
| Basic net (loss) income per share | $ | (0.04 | ) | $ | 0.02 | ||||
| Diluted net (loss) income per share | $ | (0.04 | ) | $ | 0.01 | ||||
| Weighted average common shares outstanding, basic | 189,646 | 153,490 | |||||||
| Weighted average common shares outstanding, diluted | 189,646 | 196,921 | |||||||
Consolidated Balance Sheets (in thousands) | ||||||||
2026 | 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 26,117 | $ | 28,647 | ||||
| Short-term investments | 18,667 | 17,984 | ||||||
| Accounts receivable, net | 83,693 | 89,587 | ||||||
| Inventory, net | 92,539 | 92,746 | ||||||
| Prepaid expenses and other current assets | 7,968 | 9,102 | ||||||
| Total current assets | 228,984 | 238,066 | ||||||
| Property and equipment, net | 12,025 | 12,403 | ||||||
| Other assets | 5,207 | 5,408 | ||||||
| Total assets | $ | 246,216 | $ | 255,877 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,970 | $ | 8,994 | ||||
| Accrued clinical and manufacturing liabilities | 25,166 | 26,597 | ||||||
| Accrued payroll and employee liabilities | 6,390 | 9,270 | ||||||
| Other accrued liabilities | 49,990 | 51,237 | ||||||
| Total current liabilities | 90,516 | 96,098 | ||||||
| Non-current notes payable, net | 108,307 | 107,899 | ||||||
| Non-current convertible notes payable, net | 33,327 | 32,739 | ||||||
| Other non-current liabilities | 4,929 | 4,808 | ||||||
| Total liabilities | 237,079 | 241,544 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 1,886 | 1,883 | ||||||
| Series A convertible preferred stock | 1,050 | 1,050 | ||||||
| Additional paid-in capital | 1,954,107 | 1,951,185 | ||||||
| Accumulated other comprehensive loss | (6 | ) | 4 | |||||
| Accumulated deficit | (1,947,900 | ) | (1,939,789 | ) | ||||
| Total stockholders' equity | 9,137 | 14,333 | ||||||
| Total liabilities and stockholders' equity | $ | 246,216 | $ | 255,877 | ||||
Adjusted EBITDA (unaudited) (in thousands) | |||||||||
| Three Months Ended | |||||||||
| 2026 | 2025 | ||||||||
| Net (loss) income | $ | (8,111 | ) | $ | 2,635 | ||||
| Other expense, net | 3,346 | 519 | |||||||
| Inventory reserve and write-offs | 313 | - | |||||||
| Project related legal expenses | 220 | - | |||||||
| Depreciation and amortization | 529 | 551 | |||||||
| Stock-based compensation | 2,976 | 2,511 | |||||||
| Adjusted EBITDA | $ | (727 | ) | $ | 6,216 | ||||
Investor Relations and Media Contact:
Executive Vice President, Chief Financial Officer
iduarte@herontx.com
858-251-4400
