On March 12, 2024 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, 2023 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAR 12, 2024, View Source [SID1234641066]).
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"In the fourth quarter of 2023, Heron saw continued positive momentum and an increased sales trajectory in both our acute care and oncology care franchises, illustrating how the strategic decisions made over the past year have positioned the Company for long-term success and profitability," said Craig Collard, Chief Executive Officer of Heron. "I am pleased to share this quarterly update and look forward to building upon what we achieved in the fourth quarter of 2023, providing substantial value and meaningful solutions in the acute care and oncology care settings."
Business Highlights
The ZYNRELEF Vial Access Needle ("VAN") program, to allow for the rapid preparation and administration of ZYNRELEF in the operating room, remains on track for a Prior Approval Supplement ("PAS") submission in Q2 2024 and an anticipated launch in the second half of 2024.
The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026.
Gross Margin improved to 71% for the quarter, up from 58% in the same period last year.
ZYNRELEF generated record quarterly revenues of approximately $5.6 million.
The CrossLink Life Sciences, LLC partnership finalized on January 7, 2024, will ultimately provide up to 650 additional sales representatives promoting ZYNRELEF to orthopedic surgeons.
Received FDA approval of our supplemental New Drug Application ("sNDA") for ZYNRELEF which expands the ZYNRELEF label to approximately 13 million procedures annually.
Financial Guidance for 2024
The Company reaffirms its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Product Revenues, Net
$138.0 to $158.0 million
Adjusted Operating Expenses
(Excluding Stock-Based Compensation and Depreciation and Amortization)
$108.0 to $116.0 million
Adjusted EBITDA
(Excluding Stock-Based Compensation and Depreciation and Amortization)
$(22.0) to $3.0 million
Acute Care Franchise
Acute Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2023, acute care franchise Net Product Sales were $6.1 million and $19.1 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.
ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and twelve months ended December 31, 2023 were $5.6 million and $17.7 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.
APONVIE Net Product Sales: Net Product Sales of APONVIE for the three and twelve months ended December 31, 2023 were $0.5 million and $1.4 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023.
Oncology Care Franchise
Oncology Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2023, oncology care franchise Net Product Sales were $28.1 million and $107.9 million, respectively, which increased from $26.1 million and $97.5 million, respectively, for the same periods in 2022.
CINVANTI Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2023 were $24.3 million and $94.9 million, respectively, which increased from $23.1 million and $87.3 million, respectively, for the same periods in 2022.
SUSTOL Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2023 were $3.8 million and $13.0 million, respectively, which increased from $3.0 million and $10.2 million, respectively, for the same periods in 2022.
Conference Call and Webcast
Heron will host a conference call and webcast on March 12th, 2024 at 4:30 pm ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 6135354 to join the conference call. 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 60 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 U.S. Food and Drug Administration (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. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU.
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 the only 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.