Heron Therapeutics Announces Financial Results for the Three Months Ended March 31, 2023 and Highlights Recent Corporate Updates
05/11/2023
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· Net Product Sales for First Quarter of 2023 Grew 26% to
· Appointment of
First quarter 2023 net product sales grew 26% to
With the appointment of
Acute Care Franchise
- ZYNRELEF:
- Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three months ended
March 31, 2023 was$3 .5 million. - Since launch on
July 1, 2021 throughMarch 31, 2023 , 907 unique accounts purchased ZYNRELEF with 80% of those accounts reordering the product. - The supplemental New Drug Application (sNDA) for ZYNRELEF, to support expanded use in soft tissue and orthopedic surgical procedures remains on track for the Prescription Drug User Fee Act (PDUFA) approval goal date of
October 23, 2023 . - APONVIE:
- The APONVIE (aprepitant) injectable emulsion, the only intravenous (IV) substance P/neurokinin-1 (NK1) receptor antagonist (RA) indicated for the prevention of postoperative nausea and vomiting (PONV) in adults, launched commercially in the
U.S. onMarch 6, 2023 . - Net product sales of APONVIE for the three months ended
March 31, 2023 were$0.3 million . - The
Centers for Medicare and Medicaid Services granted pass-through payment status for APONVIE, effectiveApril 1, 2023 , under C-code C9145.
Oncology Care Franchise
- Oncology Care Franchise Net Product Sales: For the three months ended
March 31, 2023 , oncology care franchise net product sales were$25.8 million , which increased 15% from$22.4 million for the same period in 2022. - CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended
March 31, 2023 were$22.8 million , compared to$20.3 million for the same period in 2022. - SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended
March 31, 2023 were$3 .0 million, compared to$2.1 million for the same period in 2022.
"We continued to make steady progress in the first quarter of 2023 at Heron, highlighted by the approval and launch of our fourth commercial product, APONVIE. We are pleased with the steady growth in the oncology care franchise and remain encouraged by the market potential for ZYNRELEF and APONVIE," said
Financial Results
Net product sales for the three months ended
For the three months ended
Heron's net loss for the three months ended
As of March 31, 2023, Heron had cash, cash equivalents and short-term investments of $60.0 million, compared to
Conference Call and Webcast
Heron will host a conference call and webcast on
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
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About APONVIE for PONV
APONVIE is a substance NK1 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
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.
About Heron Therapeutics, Inc.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, uncertainties related to market conditions; the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; the net product sales guidance for the oncology care franchise and the acute care franchise; the results of the commercial launch of APONVIE; the timing of the
Consolidated Statements of Operations (In thousands, except per share amounts) |
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Three Months Ended |
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2023 |
2022 |
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Revenues: |
(unaudited) |
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Net product sales |
$ 29,615 |
$ 23,457 |
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Operating expenses: |
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Cost of product sales |
16,854 |
11,355 |
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Research and development |
13,817 |
42,070 |
||
General and administrative |
10,853 |
9,533 |
||
Sales and marketing |
21,154 |
23,422 |
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Total operating expenses |
62,678 |
86,380 |
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Loss from operations |
(33,063) |
(62,923) |
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Other income (expense) |
295 |
(965) |
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Net loss |
$ (32,768) |
$ (63,888) |
Consolidated Balance Sheets (in thousands) |
||||
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|
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ 27,090 |
$ 15,364 |
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Short-term investments |
32,932 |
69,488 |
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Accounts receivable, net |
51,448 |
52,049 |
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Inventory |
52,059 |
54,573 |
||
Prepaid expenses and other current assets |
14,630 |
13,961 |
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Total current assets |
178,159 |
205,435 |
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Property and equipment, net |
21,512 |
22,160 |
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Right-of-use lease assets |
7,071 |
7,645 |
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Other assets |
14,136 |
15,711 |
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Total assets |
$ 220,878 |
$ 250,951 |
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LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
$ 4,065 |
$ 3,225 |
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Accrued clinical and manufacturing liabilities |
21,273 |
24,468 |
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Accrued payroll and employee liabilities |
9,510 |
13,416 |
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Other accrued liabilities |
40,290 |
38,552 |
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Current lease liabilities |
2,762 |
2,694 |
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Total current liabilities |
77,900 |
82,355 |
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Non-current lease liabilities |
4,831 |
5,499 |
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Non-current convertible notes payable, net |
149,335 |
149,284 |
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Other non-current liabilities |
241 |
241 |
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Total liabilities |
232,307 |
237,379 |
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Stockholders' equity (deficit): |
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Common stock |
1,193 |
1,191 |
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Additional paid-in capital |
1,815,592 |
1,807,855 |
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Accumulated other comprehensive income (loss) |
9 |
(19) |
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Accumulated deficit |
(1,828,223) |
(1,795,455) |
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Total stockholders' equity (deficit) |
(11,429) |
13,572 |
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Total liabilities and stockholders' equity (deficit) |
$ 220,878 |
$ 250,951 |
Investor Relations and Media Contact:
Executive Vice President, Chief Operating Officer
dszekeres@herontx.com
858-251-4447
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