On February 27, 2025 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and twelve months ended December 31, 2024, and highlighted recent corporate updates (Press release, Heron Therapeutics, FEB 27, 2025, View Source [SID1234650703]).
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"2024 was a milestone year for Heron. We delivered strong financial results, including positive Net Income for Q4 2024, achieved our operational objectives, and repositioned the business for future growth. As we move into 2025, our product ZYNRELEF is poised for transformational growth, driven by its expanded label indications, the launch of the VAN, the approval of the NOPAIN Act, and the enhanced promotional reach of the Crosslink relationship," said Craig Collard, Chief Executive Officer.
Financial Guidance for 2025
Item
2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA
(in millions)
Net Revenue
$153.0
to
$163.0
Adjusted EBITDA
$0.0
to
$8.0
Business Highlights
Partnership with Crosslink Network, LLC ("Crosslink") expands the promotional effort for ZYNRELEF within the orthopedic surgery marketplace for post-operative pain.
Expanded label indications for ZYNRELEF now cover an estimated 17 million annual targeted procedures with many more also indicated – a significant increase over prior indicated procedures, based upon data from studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty, making ZYNRELEF appropriate for a wide range of patients and appealing for broad formulary adoption.
ZYNRELEF will continue to receive separate payment from April 1, 2025, until at least the end of 2027 as the result of inclusion in the "CMS OPPS and ASC Final Rule CY 2025 Non-Opioid Policy for Pain Relief" by the Centers for Medicare & Medicaid Services ("CMS").
The ZYNRELEF VAN launched in Q4 2024, following approval by the U.S. Food and Drug Administration ("FDA") in September 2024. The VAN replaces the current vented vial spike and is expected to simplify aseptic preparation, while also significantly reducing ZYNRELEF’s withdrawal time to between twenty and forty-five seconds.
Cash, cash equivalents, and short-term investments were $59.3 million as of December 31, 2024.
Net Revenue Performance – Year Ended December 31
2024
2023
Dollar Change
Percentage Change
Acute Care
$30,064
$19,118
$10,946
57.3 %
APONVIE
$4,518
$1,391
$3,127
224.8 %
ZYNRELEF
$25,546
$17,727
$7,819
44.1 %
Oncology
$114,221
$107,926
$6,295
5.8 %
CINVANTI
$100,079
$94,869
$5,210
5.5 %
SUSTOL
$14,142
$13,057
$1,085
8.3 %
Total Net Revenue
$144,285
$127,044
$17,241
13.6 %
Net Revenue Performance – Quarter Ended December 31
2024
2023
Dollar Change
Percentage Change
Acute Care
$10,389
$6,164
$4,225
68.5 %
APONVIE
$1,932
$470
$1,462
311.1 %
ZYNRELEF
$8,457
$5,694
$2,763
48.5 %
Oncology
$30,392
$28,070
$2,322
8.3 %
CINVANTI
$26,873
$24,270
$2,603
10.7 %
SUSTOL
$3,519
$3,800
(281)
-7.4 %
Total Net Revenue
$40,781
$34,234
$6,547
19.1 %
Conference Call and Webcast
Heron will host a conference call and live webcast on Thursday, February 27, 2025, at 8:00 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. An archive of the teleconference and webcast 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 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 Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of 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.