- Reported positive YTD 2024 Adjusted EBITDA of $1.4 million
- Company expects Q4 2024 Net Revenue in the range of $37 million - $43 million
- ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN") approved in September and on track for Q4 2024 launch
- CMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both the hospital outpatient department and ambulatory surgical center settings of care
"We are pleased to report that with our prudent financial management and continued revenue growth we were able to achieve positive Adjusted EBITDA for the quarter," said Craig Collard, Chief Executive Officer. "The future looks bright as we continue to grow all product revenue. The CrossLink partnership roll out, FDA approval of the VAN in September, and inclusion in the CMS Final Rule Non-Opioid Policy for Pain Relief, positions ZYNRELEF for significant growth within the surgical setting."
"We continue to deliver on our commitment to financial efficiency while growing revenue. The team has made great strides in the transformation of Heron over the past year. We are looking forward to a strong fourth quarter which is off to a great start. As such, we are narrowing guidance for full-year 2024."
Financial Guidance for 2024
The Company narrows its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Original | Q2 Updated Guidance | Q3 Updated Guidance | |
Product Revenues, Net | $138.0 to $158.0 million | $140.0 to $146.0 million | |
Adjusted Operating Expenses | $108.0 to $116.0 million | $107.0 to $111.0 million | $101.0 to $105.0 million |
Adjusted EBITDA | $(22.0) to $3.0 million | $(10.0) to $3.0 million | $2.0 to $5.0 million |
Business Highlights
- The ZYNRELEF VAN will be available for initial use in the fourth quarter following approval by the U.S. Food and Drug Administration ("FDA") on September 24, 2024. The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds.
- 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 payment limitation for ZYNRELEF is set at $2,267.26, in line with similar products, and it will be granted the status indicator of "K1" – for Non-Opioid Drugs and Biologicals For Post-Surgical Pain Relief. The goal of the policy is to ensure there are no financial incentives to use opioids instead of non-opioid alternatives like ZYNRELEF. To qualify under the new policy, ZYNRELEF needed to meet strict criteria establishing that it does not act upon the body's opioid receptors and that it successfully demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid requirements in clinical trials or peer reviewed literature. These criteria set a strong precedent from CMS that we expect other payors to follow.
- Cash and Cash Equivalents were $70.9 million as of September 30, 2024, compared with $80.4 million on December 31, 2023.
Conference Call and Webcast
Heron will host a conference call and live webcast on Tuesday, November 12, 2024, 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.
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