Fosaprepitant Dimeglumine

精彩内容 2025年，奥赛康新药研发持续推进，1类新药利厄替尼片获批上市，1类新药注射用ASKG915、2.2类新药ASKC635干混悬剂申报临床……2024年至今，公司已有8个品种获批上市，其中多个品种为国内首批上市。目前公司有34个品种过评（11个首家），15个品种中标国采；9款重点新药处于申报临床及以上研究阶段，7个仿制药上市申请在审。 拿下8个重磅品种，首款1类新药亮眼 步入2025年，奥赛康研发管线进展不断：1类新药利厄替尼片、4类仿制药曲氟尿苷替匹嘧啶片获批上市，4类仿制药来特莫韦注射液、硫酸艾沙康唑胶囊申报上市，1类新药注射用ASKG915、2.2类新药ASKC635干混悬剂申报临床。 2024年至今，奥赛康已有8个品种获批上市，包括1类新药利厄替尼片，2类改良型新药注射用右兰索拉唑，以及仿制药曲氟尿苷替匹嘧啶片、马来酸奈拉替尼片、注射用福沙匹坦双葡甲胺、注射用硫酸艾沙康唑、枸橼酸托瑞米芬片、艾曲泊帕乙醇胺片，进一步丰富了公司的产品线。 2024年至今奥赛康获批品种 多个仿制药为国内首批上市，彰显了公司研发实力。其中，注射用硫酸艾沙康唑、艾曲泊帕乙醇胺片为国内首仿+首家过评，枸橼酸托瑞米芬片为国产第2家，曲氟尿苷替匹嘧啶片、马来酸奈拉替尼片为国产第3家，注射用福沙匹坦双葡甲胺为国产第6家。 利厄替尼片是具有全新分子结构的口服第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），用于治疗EGFR突变非小细胞肺癌（NSCLC），是公司获批上市的首个1类创新药。该药一线治疗NSCLC注册申请已于2024年8月13日获CDE承办。2024年10月，奥赛康与信达生物就利厄替尼片在中国大陆地区达成独家商业化合作。 米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）蛋白激酶抑制剂销售额超过410亿元。此前，奥赛康在该领域已有甲磺酸仑伐替尼胶囊、哌柏西利胶囊、塞瑞替尼胶囊、马来酸奈拉替尼片等品种获批上市。 34个品种过评，抢攻10亿大品种 截至目前，奥赛康已有34个品种通过/视同通过一致性评价。其中，11个品种为国内首家过评，包括注射用硫酸艾沙康唑、塞瑞替尼胶囊、地拉罗司分散片、泊沙康唑注射液、注射用兰索拉唑、沙格列汀片、注射用右雷佐生、注射用奈达铂等。 34个过评品种涉及7个治疗大类，主要集中在抗肿瘤和免疫调节剂（13个）、消化系统及代谢药（11个）。米内网数据显示，2023年中国三大终端六大市场抗肿瘤和免疫调节剂、消化系统及代谢药销售额分别超过2200亿元、2100亿元。 奥赛康通过/视同通过一致性评价品种来源：米内网一致性评价进度数据库 在国家开展的九批化药集采中，奥赛康累计有15个品种获得中选资格。未纳入集采的品种中，艾曲泊帕乙醇胺片已有11家企业过评，注射用右雷佐生、注射用福沙匹坦双葡甲胺各有7家企业过评，有机会被纳入拟于上半年开展的第十一批集采。 奥赛康聚焦高壁垒复杂制剂的开发，目前还有7个仿制药品种上市申请在审中，包括硫酸艾沙康唑胶囊、来特莫韦注射液、马立巴韦片、甲氨蝶呤注射液、注射用德拉沙星、马来酸阿伐曲泊帕片、注射用右旋雷贝拉唑钠，获批生产后将视同通过一致性评价。 其中，马来酸阿伐曲泊帕片是一款非肽类口服血小板生成素受体激动剂(TPO-RA)，适用于择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者。该药2023年在中国三大终端六大市场销售额首次突破10亿元，同比增长25.44%。 4个品种硫酸艾沙康唑胶囊、马立巴韦片、注射用德拉沙星、注射用右旋雷贝拉唑钠在国内暂无仿制药获批上市，奥赛康有望夺得国内首仿或实现国内首批上市。 9款新药在研，1类新药猛攻2200亿市场 1月23日，奥赛康披露2024年度业绩预告显示，预计2024年归属净利润1.5亿元-1.95亿元，上年同期亏损1.49亿元，同比扭亏为盈。 奥赛康表示，业绩变动原因为公司抗感染类、慢性病类产品销售增速较快，公司营业收入实现同比增长，盈利能力进一步提升；公司持续进行研发项目的分析评估与优化，聚焦推进重点优势品种的研发，研发费用同比减少；公司不断加强成本管理，降低单位生产成本，优化各类费用开支。 近年来奥赛康持续推进新药研发，通过自主研发与引进合作双向发力，重点聚焦小分子靶向创新药和肿瘤免疫生物创新药的研发，主要在研项目已有48项，包括已公开的多项重点在研化学、生物创新药，另有多款创新药处于临床前研究阶段。 奥赛康重点在研新药 除了已获批上市的1类新药利厄替尼片，目前奥赛康还有9款重点新药处于申报临床及以上研究阶段，包括7款1类新药及两款2类改良型新药，其中ASKB589注射液、注射用ASKG915、ASKC202片、注射用ASKG315均属于抗肿瘤和免疫调节剂。 7款1类新药中，ASKB589注射液（胃癌一线治疗）、麦芽酚铁胶囊（治疗成人铁缺乏症）已处于Ⅲ期临床研究阶段，上市可期；ASKG712注射液处于Ⅱa期临床研究阶段，注射用ASK0912、注射用ASKG915、ASKC202片、注射用ASKG315等多款1类新药处于Ⅰ期临床研究阶段。 资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。 本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

Achieved Q4 2024 GAAP Net Income of $3.6 million Generated full-year 2024 Net Revenue of $144.2 million , up 14% year-over-year Delivered full-year 2024 adjusted EBITDA of $8.6 million Generated ZYNRELEF® Q4 2024 Net Revenue of $8.5 million and launched the ZYNRELEF Vial Access Needle ("VAN") in December 2024 U.S. District Court ruled in favor of Heron in patent lawsuit against Fresenius Kabi USA, LLC , and upheld the validity of CINVANTI® patents which expire in 2035 CARY, N.C. , Feb. 27, 2025 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and twelve months ended December 31, 2024 , and highlighted recent corporate updates. "2024 was a milestone year for Heron. We delivered strong financial results, including positive Net Income for Q4 2024, achieved our operational objectives, and repositioned the business for future growth. As we move into 2025, our product ZYNRELEF is poised for transformational growth, driven by its expanded label indications, the launch of the VAN, the approval of the NOPAIN Act, and the enhanced promotional reach of the Crosslink relationship," said Craig Collard , Chief Executive Officer. Financial Guidance for 2025 Item 2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions) Net Revenue $153.0 to $163.0 Adjusted EBITDA $0.0 to $8.0 Business Highlights Partnership with Crosslink Network, LLC ("Crosslink") expands the promotional effort for ZYNRELEF within the orthopedic surgery marketplace for post-operative pain. Expanded label indications for ZYNRELEF now cover an estimated 17 million annual targeted procedures with many more also indicated - a significant increase over prior indicated procedures, based upon data from studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty, making ZYNRELEF appropriate for a wide range of patients and appealing for broad formulary adoption. 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 ZYNRELEF VAN launched in Q4 2024, following approval by the U.S. Food and Drug Administration ("FDA") in September 2024 . The VAN replaces the current vented vial spike and is expected to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time to between twenty and forty-five seconds. Cash, cash equivalents, and short-term investments were $59.3 million as of December 31, 2024 . Net Revenue Performance - Year Ended December 31 2024 2023 Dollar Change Percentage Change Acute Care $30,064 $19,118 $10,946 57.3 % APONVIE $4,518 $1,391 $3,127 224.8 % ZYNRELEF $25,546 $17,727 $7,819 44.1 % Oncology $114,221 $107,926 $6,295 5.8 % CINVANTI $100,079 $94,869 $5,210 5.5 % SUSTOL $14,142 $13,057 $1,085 8.3 % Total Net Revenue $144,285 $127,044 $17,241 13.6 % Net Revenue Performance - Quarter Ended December 31 2024 2023 Dollar Change Percentage Change Acute Care $10,389 $6,164 $4,225 68.5 % APONVIE $1,932 $470 $1,462 311.1 % ZYNRELEF $8,457 $5,694 $2,763 48.5 % Oncology $30,392 $28,070 $2,322 8.3 % CINVANTI $26,873 $24,270 $2,603 10.7 % SUSTOL $3,519 $3,800 (281) -7.4 % Total Net Revenue $40,781 $34,234 $6,547 19.1 % Conference Call and Webcast Heron will host a conference call and live webcast on Thursday, February 27, 2025 , 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. 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 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. Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com. About APONVIE for Postoperative Nausea and Vomiting (PONV) APONVIE 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 . 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 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. 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. Heron 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. Non-GAAP Financial Measures To 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. In 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. Adjusted EBITDA Adjusted 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 that we do not believe are indicative of 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. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted 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; we 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; adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments Adjusted Operating Expenses Adjusted 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. For more information on these non-GAAP financial measures, see the below table captioned "YTD Adjusted EBITDA." The Company has not provided a reconciliation of its guidance for adjusted EBITDA 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, and inventory reserve and asset write-offs. 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. 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. 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 potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink; the outcome of the Company's pending ANDA litigation, including potential appeals of any verdicts; 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. Heron Therapeutics, Inc. Consolidated Statements of Operations (In thousands, except per share amounts) Three months ended December 31 , Twelve months ended December 31 , 2024 2023 2024 2023 Revenues: (unaudited) Net product sales $ 40,781 $ 34,233 $ 144,285 $ 127,044 Cost of product sales 10,229 9,885 38,648 65,105 Gross Profit 30,552 24,348 105,637 61,939 Operating expenses: Research and development 3,178 7,803 16,683 39,133 General and administrative 12,144 14,437 53,397 65,778 Sales and marketing 11,057 12,328 47,085 67,643 Total operating expenses 26,379 34,568 117,165 172,554 Income (loss) from operations 4,173 (10,220) (11,528) (110,615) Other (expense) income, net (510) (504) (2,052) 56 Net loss $ 3,663 $ (10,724) $ (13,580) $ (110,559) Basic and diluted net income (loss) per share $ 0.02 $ (0.07) $ (0.09) $ (0.80) Weighted average common shares outstanding, basic and diluted 153,151 151,152 152,449 138,135 Heron Therapeutics, Inc. Consolidated Balance Sheets (in thousands) December 31 ,2024 December 31 ,2023 ASSETS Current assets: Cash and cash equivalents $ 25,802 $ 28,677 Short-term investments 33,481 51,732 Accounts receivable, net 78,881 60,137 Inventory 53,160 42,110 Prepaid expenses and other current assets 17,690 6,118 Total current assets 209,014 188,774 Property and equipment, net 14,863 20,166 Right-of-use lease assets 2,787 5,438 Other assets 6,483 8,128 Total assets $ 233,147 $ 222,506 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 11,709 $ 3,240 Accrued clinical and manufacturing liabilities 25,402 22,291 Accrued payroll and employee liabilities 9,554 9,224 Other accrued liabilities 41,755 41,855 Current lease liabilities 3,037 3,075 Total current liabilities 91,457 79,685 Non-current lease liabilities - 2,800 Non-current notes payable, net 25,026 24,263 Non-current convertible notes payable, net 149,700 149,490 Other non-current liabilities 615 241 Total liabilities 266,798 256,479 Stockholders' deficit: Common stock 1,521 1,503 Additional paid-in capital 1,884,409 1,870,525 Accumulated other comprehensive (loss) income 13 13 Accumulated deficit (1,919,594) (1,906,014) Total stockholders' deficit (33,651) (33,973) Total liabilities and stockholders' deficit $ 233,147 $ 222,506 Heron Therapeutics, Inc. YTD Adjusted EBITDA (in thousands) GAAP YTD 2024 Depreciation Stock-Based Compensation Inventory Reserve & Write-Off Asset Write-Off Adjusted YTD 2024 Net Product Sales $ 144,285 $ - $ - $ - $ - $ 144,285 Cost of Product Sales 38,648 2,117 - 2,474 - 34,057 Gross profit 105,637 (2,117) - (2,474) - 110,228 Operating Expenses: Research and development 16,683 189 1,856 - 2,210 12,428 General and administrative 53,397 149 7,138 - - 46,110 Sales and marketing 47,085 37 3,968 - - 43,080 Total Operating Expense 117,165 375 12,962 - 2,210 101,618 (Loss) Income from Operations $ (11,528) $ (2,492) $ (12,962) $ (2,474) $ (2,210) $ 8,610 Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com858-251-4400 View original content to download multimedia:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-fourth-quarter-and-full-year-2024-financial-results-and-highlights-recent-corporate-updates-302387150.html SOURCE Heron Therapeutics, Inc.