Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance

PR Newswire11-12

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...

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}","selectors":"article","filters":"","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2482700781","pubTimestamp":1731416100,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"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  extended-release solution Vial Access Needle  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.\"","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4563":"昨日强势股","AC":"Associated Capital Group, Inc.","RA":"Brookfield Real Assets Income Fund Inc.","MEC":"Mayville Engineering Company Inc.","BK4139":"生物科技","HRTX":"Heron Therapeutics Inc.","B":"巴恩斯","BK4135":"资产管理与托管银行","BK4161":"工业机械","CINV":"CRUCIAL INNOVATIONS CORP."},"translate_title":"Heron Therapeutics公布2024年第三季度财务业绩并缩小财务指引","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AC":1,"B":1,"CINV":1,"HRTX":1,"MEC":1,"RA":1},"content_text":"Reported positive YTD 2024 Adjusted EBITDA of $1.4 million\nCompany expects Q4 2024 Net Revenue in the range of $37 million - $43 million\nZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle (\"VAN\") approved in September and on track for Q4 2024 launch\nCMS 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\n\nSAN DIEGO, Nov. 12, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (\"Heron\" or the \"Company\"), a commercial-stage biotechnology company, today announced financial results for the three and nine months ended September 30, 2024, and highlighted recent corporate updates.\n\"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.\"\n\"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.\"\nFinancial Guidance for 2024 \nThe Company narrows its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:\n\n\n\n\n\nOriginal \nQ2 Updated Guidance \nQ3 Updated Guidance \n\n\nProduct Revenues, Net \n$138.0 to $158.0 million \n$140.0 to $146.0 million \n\n\nAdjusted Operating Expenses \n$108.0 to $116.0 million \n$107.0 to $111.0 million \n$101.0 to $105.0 million \n\n\nAdjusted EBITDA \n$(22.0) to $3.0 million \n$(10.0) to $3.0 million \n$2.0 to $5.0 million \n\n\n\n\nBusiness Highlights\n\nThe 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.\nZYNRELEF 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.\nCash and Cash Equivalents were $70.9 million as of September 30, 2024, compared with $80.4 million on December 31, 2023.\n\nAcute Care Franchise\n\nAcute Care Franchise Net Product Sales: For the three and nine months ended September 30, 2024, acute care franchise Net Product Sales were $7.4 million and $19.7 million, respectively, compared to $4.7 million and $12.9 million, respectively, for the same period in 2023.\nZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF for the three and nine months ended September 30, 2024 were $6.3 million and $17.1 million, respectively, compared to $4.4 million and $12.0 million, respectively, for the same period in 2023.\nAPONVIE® Net Product Sales: Net Product Sales of APONVIE for the three and nine months ended September 30, 2024 were $1.1 million and $2.6 million, respectively, compared to $0.3 million and $0.9 million, respectively, for the same period in 2023.\n\nOncology Care Franchise \n\nOncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2024, oncology care franchise Net Product Sales were $25.4 million and $83.8 million, respectively, compared to $26.7 million and $79.9 million for the same period in 2023.\nCINVANTI® Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2024 were $22.6 million and $73.2 million, compared to $23.3 million and $70.6 million for the same period in 2023.\nSUSTOL® Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2024 were $2.8 million and $10.6 million, respectively, compared to $3.4 million and $9.3 million, respectively, for the same period in 2023.\n\nConference Call and Webcast\nHeron 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.\nAbout ZYNRELEF for Postoperative Pain\nZYNRELEF 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 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.\nPlease see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.\nAbout APONVIE for Postoperative Nausea and Vomiting (PONV)\nAPONVIE 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.\nPlease see full prescribing information at www.APONVIE.com.\nAbout CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention\nCINVANTI, 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 a 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.\nPlease see full prescribing information at www.CINVANTI.com.\nAbout SUSTOL for CINV Prevention\nSUSTOL 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).\nPlease see full prescribing information at www.SUSTOL.com.\nAbout Heron Therapeutics, Inc.\nHeron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.\nNon-GAAP Financial Measures\nTo supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting.\nIn our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis.\nAdjusted EBITDA\nAdjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.\nThere are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as:\n\nadjusted EBITDA excludes depreciation and amortization and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;\nwe exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;\nwe exclude impairment of long-lived assets, the amount and/or frequency of which are not part of our underlying business.\nwe exclude inventory write-downs (and write-ups should they occur), the amount and/or frequency of which are not part of our underlying business.\nadjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;\nadjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;\nadjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; and\nwe exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business.\n\nAdjusted Operating Expenses\nAdjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, depreciation and amortization, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations.\nThe Company has not provided a reconciliation of its full-year 2024 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company's control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period.\nForward-looking Statements\nThis 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. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; revenue, adjusted EBITDA and other financial guidance provided by the Company; the results of the commercial launch of APONVIE; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system; the timing of the Company's development of the VAN program and receipt of required regulatory approvals; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with CrossLink Life Sciences, LLC (\"CrossLink\"); the outcome of the Company's pending ANDA litigation; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption \"Risk Factors.\" Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.\n\n\n\n\nHeron Therapeutics, Inc. \n\n\nConsolidated Statements of Operations \n\n\n (In thousands, except per share amounts) \n\n\n\n\n\n\n\nThree months ended September 30, \n\nNine months ended September 30, \n\n\n\n\n2024 \n\n2023 \n\n2024 \n\n2023 \n\n\nRevenues: \n\n(unaudited) \n\n\nNet product sales \n\n$ 32,810 \n\n$ 31,434 \n\n$ 103,504 \n\n$ 92,811 \n\n\nCost of product sales \n\n9,458 \n\n18,208 \n\n28,420 \n\n55,220 \n\n\nGross Profit \n\n23,352 \n\n13,226 \n\n75,084 \n\n37,591 \n\n\nOperating expenses: \n\n\n\n\n\n\n\n\n\n\nResearch and development \n\n4,465 \n\n9,285 \n\n13,505 \n\n31,331 \n\n\nGeneral and administrative \n\n12,373 \n\n15,914 \n\n41,252 \n\n51,340 \n\n\nSales and marketing \n\n10,972 \n\n12,956 \n\n36,028 \n\n55,315 \n\n\nTotal operating expenses \n\n27,810 \n\n38,155 \n\n90,785 \n\n137,986 \n\n\nLoss from operations \n\n(4,458) \n\n(24,929) \n\n(15,701) \n\n(100,395) \n\n\nOther (expense) income, net \n\n(390) \n\n(79) \n\n(1,542) \n\n560 \n\n\nNet loss \n\n$ (4,848) \n\n$ (25,008) \n\n$ (17,243) \n\n$ (99,835) \n\n\nBasic and diluted net loss per share \n\n$ (0.03) \n\n$ (0.17) \n\n$ (0.11) \n\n$ (0.75) \n\n\nWeighted average common shares outstanding, basic and diluted \n\n152,830 \n\n144,990 \n\n152,213 \n\n133,747 \n\n\n\n\n\n\n\n\nHeron Therapeutics, Inc. \n\n\nConsolidated Balance Sheets \n\n\n(in thousands) \n\n\n\n\n\n\nSeptember 30,2024 \n\nDecember 31,2023 \n\n\n\n(Unaudited) \n\n\n\n\nASSETS \n\n\n\n\n\nCurrent assets: \n\n\n\n\n\nCash and cash equivalents \n$ 25,741 \n\n$ 28,677 \n\n\nShort-term investments \n45,149 \n\n51,732 \n\n\nAccounts receivable, net \n67,039 \n\n60,137 \n\n\nInventory \n45,950 \n\n42,110 \n\n\nPrepaid expenses and other current assets \n11,308 \n\n6,118 \n\n\nTotal current assets \n195,187 \n\n188,774 \n\n\nProperty and equipment, net \n15,414 \n\n20,166 \n\n\nRight-of-use lease assets \n3,469 \n\n5,438 \n\n\nOther assets \n6,707 \n\n8,128 \n\n\nTotal assets \n$ 220,777 \n\n$ 222,506 \n\n\nLIABILITIES AND STOCKHOLDERS' DEFICIT \n\n\n\n\n\nCurrent liabilities: \n\n\n\n\n\nAccounts payable \n$ 10,188 \n\n$ 3,240 \n\n\nAccrued clinical and manufacturing liabilities \n22,859 \n\n22,291 \n\n\nAccrued payroll and employee liabilities \n8,531 \n\n9,224 \n\n\nOther accrued liabilities \n40,717 \n\n41,855 \n\n\nCurrent lease liabilities \n3,249 \n\n3,075 \n\n\nTotal current liabilities \n85,544 \n\n79,685 \n\n\nNon-current lease liabilities \n522 \n\n2,800 \n\n\nNon-current notes payable, net \n24,828 \n\n24,263 \n\n\nNon-current convertible notes payable, net \n149,647 \n\n149,490 \n\n\nOther non-current liabilities \n241 \n\n241 \n\n\nTotal liabilities \n260,782 \n\n256,479 \n\n\nStockholders' deficit: \n\n\n\n\n\nCommon stock \n1,517 \n\n1,503 \n\n\nAdditional paid-in capital \n1,881,695 \n\n1,870,525 \n\n\nAccumulated other comprehensive (loss) income \n40 \n\n13 \n\n\nAccumulated deficit \n(1,923,257) \n\n(1,906,014) \n\n\nTotal stockholders' deficit \n(40,005) \n\n(33,973) \n\n\nTotal liabilities and stockholders' deficit \n$ 220,777 \n\n$ 222,506 \n\n\n\n\nInvestor Relations and Media Contact: Ira DuarteExecutive Vice President, Chief Financial OfficerHeron Therapeutics, Inc. iduarte@herontx.com 858-251-4400\n\n\n\n\n\n View original content to download multimedia:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-third-quarter-2024-financial-results-and-narrows-financial-guidance-302302018.html\nSOURCE Heron Therapeutics, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; 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