On May 7, 2024 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2024 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAY 7, 2024, View Source [SID1234642773]).

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"We are extremely pleased with our ability to improve the financial efficiency of the business by growing revenues, improving margins, and reducing expenses. We made tremendous progress this quarter by promptly training CrossLink sales representatives and integrating them into our commercial execution, while also training our own commercial team on the newly expanded label for ZYNRELEF," said Craig Collard, Chief Executive Officer of Heron.

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 late 2024.

The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026.

The training and integration of CrossLink Life Sciences, LLC ("CrossLink") sales representatives to promote ZYNRELEF to orthopedic surgeons has progressed quickly, with a total of 191 CrossLink sales representatives, to date, having completed training and actively engaging with their respective physicians. As we continue to expand our reach across the nation, we anticipate an additional fifty CrossLink sales representatives will complete training and be ready to engage with their respective physicians on ZYNRELEF within the next thirty days.

Following the FDA’s approval for the expanded indication of ZYNRELEF on January 23, 2024, ZYNRELEF is now approved for postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

Heron will host its Investor Day event on Wednesday, May 15, 2024, from 9:30 a.m. – 12:30 p.m. ET in New York, New York. Members of Heron’s leadership team will give presentations during the event highlighting Heron’s recent organizational transformation and the commercial opportunity across the acute care and oncology franchises. To register for the event to attend in-person or virtually, please click here.
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 months ended March 31, 2024, acute care franchise Net Product Sales were $5.5 million, which increased from $3.8 million for the same period in 2023.

ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three months ended March 31, 2024 was $5.0 million, which increased from $3.5 million for the same period in 2023.

APONVIE Net Product Sales: Net Product Sales of APONVIE for the three months ended March 31, 2024 was $0.5 million, which increased from $0.3M, for the same period in 2023.
Oncology Care Franchise

Oncology Care Franchise Net Product Sales: For the three months ended March 31, 2024, oncology care franchise Net Product Sales was $29.2 million, which increased from $25.8 million for the same period in 2023.

CINVANTI Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2024 was $25.6 million, which increased from $22.8 million for the same period in 2023.

SUSTOL Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2024 was $3.6 million, which increased from $3.0 million, for the same period in 2023.
Conference Call and Webcast

Heron will host a conference call and webcast on May 7, 2024 at 8:30 a.m. 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 1497932 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 sixty days following the call.