Press Release: Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2021 and Highlights Recent Corporate Updates

Dow Jones · 2022-02-28 16:05

-- Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2021 were $2.5 million and $9.9 million, respectively, compared to $0.3 million and $0.8 million, respectively, for the same periods in 2020. -- 2022 Oncology Care Franchise Net Product Sales Guidance: Heron currently expects the first quarter of 2022 net product sales for the oncology care franchise in the range of $20 million to $22 million. The Company is not providing full-year 2022 financial guidance at this time due to the uncertainty around the COVID-19 pandemic and its impact on patient care.-- Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2021 were $17.4 million and $73.5 million, respectively, compared to $20.3 million and $87.8 million, respectively, for the same periods in 2020. -- In the fourth quarter of 2021, Heron received FDA approval of a manufacturing supplement to the NDA for CINVANTI to add larger-scale manufacturing of CINVANTI. This approval will significantly reduce the cost of products sales.-- 2021 Oncology Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2021, oncology care franchise net product sales were $19.9 million and $83.4 million, respectively, compared to $20.6 million and $88.6 million, respectively, for the same periods in 2020. During 2021, Heron's oncology care franchise net product sales have stabilized with moderate growth expected in 2022.-- ZYNRELEF: -- The ZYNRELEF (bupivacaine and meloxicam) extended-release solution New Drug Application (NDA) was approved by the U.S. Food and Drug Administration (FDA) in May 2021. In December 2021, the FDA approved our supplemental New Drug Application (sNDA) for ZYNRELEF, which significantly expanded the indication statement, now covering approximately 7 million procedures annually. ZYNRELEF is currently indicated for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. The FDA also agreed to Heron's proposal for a second sNDA, planned for later this year, designed to further expand the indication statement. -- ZYNRELEF became commercially available in the U.S. on July 1, 2021, and net product sales for the three and twelve months ended December 31, 2021 were $0.8 million and $2.9 million, respectively. -- During the first two quarters of commercial launch ended December 31, 2021, over 300 unique accounts purchased ZYNRELEF with 70% of those accounts reordering the product. ZYNRELEF end-user (hospitals and ambulatory surgical centers (ASC)) demand units' volume sales increased by 126% in the fourth quarter over the prior quarter. -- As of February 25, 2022, ZYNRELEF has received 260 formulary approvals, with over a 90% hospital approval rate, and over 60% of formulary approvals have been for unrestricted use. Over 100 additional formulary review meetings are scheduled through March 31, 2022. -- Multiple commercial and Medicaid payers covering over 120 million lives have agreed to reimburse ZYNRELEF outside of the surgical bundle payment for surgeries performed in ASCs, with many of these covered lives also having their hospital outpatient procedures reimbursed outside the surgical bundle payment. Commercial and Medicaid payers represent more than 80% of our target patients in the outpatient setting. On November 2, 2021, we were issued a specific C-code (C9088) for separate reimbursement in the ASC setting of care effective January 1, 2022. -- In the fourth quarter of 2021, Heron received FDA approval of two manufacturing supplements to the NDA for ZYNRELEF to add a large-scale secondary supplier of our proprietary polymer and to add larger-scale manufacturing of ZYNRELEF. These approvals will allow for the manufacturing of millions of doses of ZYNRELEF annually at a significantly reduced cost of products sales. -- NDA Submission for HTX-019 for Prevention of PONV in Adults Under Review: A 505(b)(2) NDA for HTX-019 for the prevention of postoperative nausea and vomiting (PONV) in adults was submitted to the FDA in November 2021. The FDA accepted the NDA for filing and set a Prescription Drug User Fee Act (PDUFA) goal date of September 17, 2022.

Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2021 and Highlights Recent Corporate Updates

- ZYNRELEF(R) has received 260 formulary approvals since initial launch in July 2021, with over a 90% hospital approval rate and over 60% of approvals have been for unrestricted usage -

- Over 300 unique accounts purchased ZYNRELEF with 70% of those accounts reordering the product -

- FDA approval received in December 2021 for a significant indication expansion of ZYNRELEF, now covering approximately 7 million procedures annually -

- CMS has issued a specific C-code in November 2021 for ZYNRELEF to support separate reimbursement for Medicare patients in the ASC setting of care -

- NDA Submission for HTX-019 for prevention of PONV in adults accepted by FDA with a PDUFA goal date of September 17, 2022 -

PR Newswire

SAN DIEGO, Feb. 28, 2022

SAN DIEGO, Feb. 28, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced financial results for the three and twelve months ended December 31, 2021 and highlighted recent corporate updates.

Recent Corporate Updates

Acute Care Franchise

Oncology Care Franchise

CINVANTI(R)

SUSTOL(R)

"2021 was a tremendous year for Heron. The approval and successful commercial launch of ZYNRELEF was a game-changing milestone for patients, healthcare providers, and pain management. We are extremely pleased with the very positive feedback from patients and surgeons about the benefits of ZYNRELEF, which has resulted in a high reorder rate. With our new broader label for ZYNRELEF and the recent rapid decline of COVID, we expect to significantly expand ZYNRELEF's commercial footprint this year, " said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In oncology care, our CINV portfolio has stabilized and is poised for sales growth in 2022."

Financial Results

Net product sales for the three and twelve months ended December 31, 2021 were $20.7 million and $86.3 million, respectively, compared to $20.6 million and $88.6 million, respectively, for the same periods in 2020.

Heron's net loss for the three and twelve months ended December 31, 2021 was $54.6 million and $220.7 million, or $0.54 per share and $2.24 per share, respectively, compared to $62.3 million and $227.3 million, or $0.68 per share and $2.50 per share, respectively, for the same periods in 2020. Net loss for the three and twelve months ended December 31, 2021 included non-cash, stock-based compensation expense of $12.9 million and $46.9 million, respectively, compared to $16.0 million and $50.2 million, respectively, for the same periods in 2020.

As of December 31, 2021, Heron had cash, cash equivalents and short-term investments of $157.6 million, compared to $208.5 million as of December 31, 2020. Net cash used for operating activities for the year ended December 31, 2021 was $203.4 million, compared to $184.8 million for the same period in 2020. The increase in our net cash used for operating activities was primarily due to changes in working capital related to the launch of ZYNRELEF in July 2021, including manufacturing of commercial inventory. We expect net cash used for operating activities of $44 million to $48 million in the first quarter of 2022. We anticipate that our net cash usage will continue to moderate lower throughout 2022 as net product sales increase and we realize cost savings from anticipated larger-scale manufacturing.

Conference Call and Webcast

Heron will host a conference call and webcast on February 28, 2022 at 4:30 p.m. ET. The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 9276143 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

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February 28, 2022 16:05 ET (21:05 GMT)