附件99.1
新闻稿
Ascendis Pharma报告2024年第三季度财务业绩
– YORVIPATH将在美国推出，产品预计于1月中旬上市 中旬 2025; 不包括美国 YORVIPATH在第三季度的营业收入为8.5百万欧元
– TransCon CNP NDA submission for achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025
– SKYTROFA Q3 revenue of €47.2 million – 60%+ year-over-year volume growth offset by current and prior period sales deductions
– Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be €200 - €220 million, and full year 2024 operating expenses of approximately €600 million
– Novo Nordisk collaboration for the development of product candidates in metabolic and cardiovascular diseases, including a once-monthly 全球肽-1 receptor agonist, signed last week, seeking to close before the end of 2024
– Conference call today at 4:30 pm Et
COPENHAGEN, Denmark, November2024年14日（环球新闻社） - Ascendis Pharma A/S（纳斯达克：ASND）今天宣布了截至2024年9月30日的第三季度财务业绩，并提供了业务更新。
“2024年对Ascendis来说是又一个转型之年。现在，我们的三个内分泌罕见病项目都已经提供了临床差异化的关键数据，每一个都展示了解决重大未满足医疗需求的潜力，以及每一个都有望成为拳头产品。我们已经准备好并对即将在2025年1月中旬在美国推出YORVIPATH的产品充满期待，产品可供性预计为”。 2025年1月中旬 ascendis pharma公司总裁兼首席执行官Jan Mikkelsen表示：“此外，我们与诺和诺德的新合作伙伴关系突显了我们延续TransCon平台成功的能力，并使Ascendis能够惠及患者，在这一庞大、高交易量的疗法领域获取巨大价值。”
精选亮点 & 预期的2024年重要事件
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| • | SKYTROFA revenue for the third quarter of 2024 totaled €47.2 million compared to €47.0 million during the same period in 2023. Volume growth was offset by higher sales deductions and a negative adjustment to prior period sales deductions of €2.5 million. |
| • | SKYTROFA revenue for the first nine months of 2024 totaled €138.5 million, a 21% year-over-year increase compared to €114.4 million during the same period of 2023. Volume growth was partially offset by higher sales deductions. In addition, sales deductions attributable to periods prior to January 1, 2024 totaled €9.3 million. |
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| • | Submitted U.S. Food & Drug Administration (FDA) supplemental Biologics License Application for TransCon hGH for the treatment of adults with growth hormone deficiency. |
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| • | Expect to initiate a basket trial evaluating SKYTROFA in other established daily growth hormone indications in the first half of 2025. |
| • | TransCon PTH |
| • | YORVIPATH launching in U.S. with our expanded U.S. field teams engaging with health care providers, our Ascendis Signature Access Program accepting prescriptions and enrolling patients starting in December in preparation for product availability in mid-January 2025 |
| • | Third quarter YORVIPATH revenue outside the U.S. totaled €8.5 million, a sequential quarter-over-quarter revenue increase of more than 60%, reflecting growing physician and patient demand with now over 600 patients on treatment, partially offset by accruals reflecting the end of the free pricing period in the third quarter. Final pricing in Germany is expected to be completed next year. |
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| • | Announced positive topline data from pivotal ApproaCH Trial with children with achondroplasia (ages 2-11 years) treated with once-weekly TransCon CNP. |
| • | Plan to submit New Drug Application (NDA) to the FDA for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and a Marketing Authorisation Application (MAA) for the treatment of children with achondroplasia to the European Medicines Agency during the third quarter of 2025. |
| • | 预计于2025年第二季度公布COACH项目的顶线第26周数据，这是关于悬停生长素和TransCon CNP试验在骨发育障碍儿童（年龄 2-11 岁）方面的试验。 |
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| • | 在ESMO 2024上发布了第一批铂类耐药卵巢癌（PROC）队列的1/2期IL-Believe试验结果。初步数据显示在重度PROC患者中出现临床效果，并且TransCon 项目的结果 表明 通过TKI预处理后的ALK阳性患者筛选进行扩大队列试验以评估NVL-655的疗效和安全性。 结 IL-2 ß/g in combination with chemotherapy was generally well-tolerated. |
| • | Recently, we closed enrollment to dose expansion cohorts involving TransCon TLR7/8 Agonist in the transcendIt-101 and IL Believe trials to prioritize our efforts on TransCon IL-2 ß/g. |
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| • | 战略合作 |
| • | Ascendis Pharma A/S于11月授予Novo Nordisk A/S独家、多产品、全球许可，使用TransCon技术平台开发、制造和商业化Novo Nordisk专有产品，涉及代谢疾病和心血管疾病的独家许可。合作中的主要项目是一种一月一次的受体激动剂产品候选药物，最初将瞄准肥胖症和2型糖尿病。对于主要项目，Ascendis将有资格获得高达2.85亿美元的预付款、开发和监管里程碑支付，以及基于销售的里程碑支付和逐渐增加的分层支付。 逐产品 独家许可证涉及心血管疾病。合作中的主要项目是一种一月一次的受体激动剂产品候选药物，最初将瞄准肥胖症和2型糖尿病。 全球肽-1 对于主要项目，Ascendis有资格获得高达2850万美元的总付款，其中包括预付款、开发和监管里程碑支付，以及基于销售的里程碑支付和逐渐递增的分层支付 |
| • | 对于主要项目，Ascendis将有资格获得高达2850万美元的总付款，其中包括预付款、开发和监管里程碑支付，以及基于销售额的里程碑支付和递增的分层支付 中等单数 全球净销售额上的数字版税。 |
| • | 拟诺和诺德将负责升和生物公司的早期开发成本，以及临床开发、监管、商业制造和商业化活动。 |
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| • | 截至2024年9月30日，ascendis pharma拥有现金、现金等价物和可交易证券，合计626欧元，与2023年12月31日的399欧元相比。 |
| • | 2024年全年SKYTROFA营业收入，不包括与之前年度相关的销售扣除项，预计为200-220百万欧元。 |
| • | 预计2024年总营业费用（销售、一般及行政以及研发费用）约为600百万欧元。 |
2024年第三季度财务业绩
2024年第三季度总收入为57.8百万欧元，而2023年同期为48.0百万欧元。总收入同比增长的主要原因是2024年第一季度YORVIPATH商业推出后贡献的8.5百万欧元收入。 非产品2024年第三季度非产品收入为2.1百万欧元，而2023年同期为1.1百万欧元。
| 总营业收入 (以千欧元为单位) |
截至三个月的数据 9月30日, |
截至九个月 9月30日, |
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| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 外部客户营业收入 |
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| 商品的商业销售 |
55,710 | 46,968 | 153,598 | 114,414 | ||||||||||||
| 许可证 |
851 | 571 | 26,490 | 1,774 | ||||||||||||
| 其他 |
1,272 | 495 | 9,637 | 12,828 | ||||||||||||
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57,833 | 48,034 | 189,725 | 129,016 | ||||||||||||
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2024年第三季度的研发(R&D)费用为73.5百万欧元，相比之下，2023年同期为111.4百万欧元。这一下降主要是由于TransCon hgh、TransCon PTH和TransCon CNP以及Eyconis的外部开发成本较低所致分拆。
2024年第三季度销售、管理和行政支出为69.8百万欧元，而2023年同期为63.6百万欧元。主要增加是因为员工成本增加，包括商业扩张的影响。
2024年第三季度总营业费用为143.4百万欧元，而2023年同期为175.1百万欧元。
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2024年第三季度净财务收入为2.9百万欧元，而2023年同期净财务支出为20.4百万欧元。这种变化主要是由货币波动的影响造成的。
截至2024年第三季度，Ascendis Pharma报告的净亏损为99.2百万欧元，每股1.72欧元（基本和摊薄），而2023年同期的净亏损为162.2百万欧元，每股2.88欧元（基本和摊薄）。
截至2024年9月30日，Ascendis Pharma的现金、现金等价物和市场证券总计为625.5百万欧元，而2023年12月31日为399.4百万欧元。截至2024年9月30日，Ascendis Pharma拥有60642144普通股，其中包括公司持有的881730普通股代表的ADS。
电话会议和网络研讨会信息：
Ascendis Pharma将于今天下午4:30（东部时间）举行电话会议和网络直播，讨论其2024年第三季度财务业绩。
希望参与的人可以访问现场网络广播 这里，或者提前注册参加电话会议 这里。现场网络广播的链接也将在Ascendis Pharma网站的投资者与新闻栏目上提供https://investors.ascendispharma.com。活动结束后，Ascendis Pharma网站的这一栏目将提供网络广播的重播，持续30天。
hgh集团正在应用其创新的TransCon技术平台，打造一个领先的、完全一体化的生物制药公司，专注于在患者生活中产生有意义的影响。Ascendis秉承患者、科学和激情的核心价值观，利用其TransCon技术来创造新的、潜在的治疗方法。 最佳类别 Ascendis总部位于丹麦哥本哈根，在欧洲和美国设有额外的设施。请访问 ascendispharma.com了解更多。
前瞻性声明
本新闻稿包含涉及重大风险和不确定性的前瞻性声明。除历史事实声明外，本新闻稿中包括的Ascendis未来运营、计划和管理目标的所有声明均属于前瞻性声明。此类声明的示例包括但不限于 (i) YORVIPATH在美国的推出时间；(ii) TransCon CNP的新药申请和MAA提交时间；(iii) 关于2024年SKYTROFA营收和营业费用预测；(iv) 诺和诺德合作的完成时间；(v) Ascendis三个内分泌罕见病项目解决重大未满足医疗需求和实现巨头地位的能力；(vi) Ascendis延续TransCon平台成功并在代谢和心血管疾病领域实现重要价值的能力；(vii) Turner综合征2期New InsiGHTS试验的最终结果公布时间；(viii) 评估SKYTROFA在其他每日生长激素适应症中的篮子试验启动时间；(ix) Ascendis Signature Access Program开始接受处方和招募患者的时间；(x) YORVIPATH在德国定价最终结果的时间；(xi) COACH项目，儿童髂小背短孩童TransCon hGH和TransCon CNP联合试验26周最终数据公布时间；(xii) Ascendis
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revenues from the Novo Nordisk collaboration; (xiii) Novo Nordisk’s responsibilities under the collaboration; (xiv) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xv) Ascendis’ use of its TransCon technologies to create new and potentially 最佳类别 therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or 在市场上 products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, ascendis pharma, Ascendis Pharma标志, 公司标志, TransCon, SKYTROFA® ® 是Ascendis Pharma集团拥有的商标。 ©
2024年11月Ascendis Pharma a/s。
| 投资者联系方式： | 媒体联系： | |||
| 斯科特·史密斯 | Melinda Baker | |||
| Ascendis Pharma | Ascendis Pharma | |||
| ir@ascendispharma.com | +1 (650) 709-8875 | |||
| media@ascendispharma.com |
Patti Bank
ICR Healthcare
+1 (415) 513-1284
patti.bank@icrhealthcare.com
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财务表格如下
ascendis pharma a/s
综合利润表或损益及综合利润/(损益)
| 截至三个月 9月30日, |
截至九个月 9月30日, |
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| 2024 | 2023 | 2024 | 2023 | |||||||||||||
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| 收入 |
57,833 | 48,034 | 189,725 | 129,016 | ||||||||||||
| 销售成本 |
11,201 | 7,388 | 30,235 | 24,938 | ||||||||||||
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| 毛利润 |
46,632 | 40,646 | 159,490 | 104,078 | ||||||||||||
| 研发费用 |
73,544 | 111,439 | 227,708 | 322,573 | ||||||||||||
| 销售、一般和管理费用 |
69,831 | 63,614 | 210,928 | 200,435 | ||||||||||||
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| 营业利润/(亏损) |
(96,743 | ) | (134,407 | ) | (279,146 | ) | (418,930 | ) | ||||||||
| 合营企业利润（亏损）份额 |
(4,367 | ) | (6,794 | ) | (15,485 | ) | (15,471 | ) | ||||||||
| 财务收入 |
28,279 | 4,142 | 29,262 | 76,985 | ||||||||||||
| 财务费用 |
25,347 | 24,519 | 70,488 | 35,640 | ||||||||||||
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| 税前利润（亏损） |
(98,178 | ) | (161,578 | ) | (335,857 | ) | (393,056 | ) | ||||||||
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(1,020 | ) | (645 | ) | (3,758 | ) | (1,513 | ) | ||||||||
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(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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| 归属于公司业主 |
(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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€ | (1.72 | ) | € | (2.88 | ) | € | (5.93 | ) | € | (7.02 | ) | ||||
| 基本和稀释计算所用的股数 |
57,535,349 | 56,272,698 | 57,255,764 | 56,194,956 | ||||||||||||
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(99,198 | ) | (162,223 | ) | (339,615 | ) | (394,569 | ) | ||||||||
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| 外币翻译差异 |
154 | 571 | 232 | (1,232 | ) | |||||||||||
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| 本期其他综合收益/（综合损失），净额 |
154 | 571 | 232 | (1,232 | ) | |||||||||||
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| 注3——重要的会计判断和估计 |
(99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | ||||||||
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| 归属于公司业主 |
(99,044 | ) | (161,652 | ) | (339,383 | ) | (395,801 | ) | ||||||||
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ascendis pharma a/s
合并财务状况表
| (以欧元'000) | 9月30日, 2024 |
12月31日 2023 |
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| 资产 |
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| 非当前 资产 |
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| 无形资产 |
4,106 | 4,419 | ||||||
| 物业、厂房和设备 |
97,522 | 110,634 | ||||||
| 对联营企业的投资 |
16,213 | 5,686 | ||||||
| 其他应收款 |
2,202 | 2,127 | ||||||
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| 120,043 | 122,866 | |||||||
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| 流动资产 |
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| 存货 |
265,433 | 208,931 | ||||||
| 应收账款 |
33,098 | 35,874 | ||||||
| 所得税应收款 |
1,995 | 802 | ||||||
| 其他应收款 |
15,259 | 19,097 | ||||||
| 预付款项 |
32,440 | 38,578 | ||||||
| 可交易证券 |
— | 7,275 | ||||||
| 现金及现金等价物 |
625,515 | 392,164 | ||||||
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| 973,740 | 702,721 | |||||||
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| 总资产 |
1,093,783 | 825,587 | ||||||
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| 股东权益和负债 |
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| 股权 |
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| 股本 |
8,143 | 7,749 | ||||||
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(105,463 | ) | (153,446 | ) | ||||
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| 总股本 |
(97,320 | ) | (145,697 | ) | ||||
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| 非当前 负债 |
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| 借款 |
338,930 | 222,996 | ||||||
| 合同责任 |
5,000 | 5,949 | ||||||
| 递延所得税负债 |
8,716 | 5,830 | ||||||
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| 352,646 | 234,775 | |||||||
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| 流动负债 |
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| 931,527 |
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| 借款 |
422,064 | 407,095 | ||||||
| 衍生负债 |
168,346 | 143,296 | ||||||
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| 590,410 | 550,391 | |||||||
| 其他流动负债 |
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| 借款 |
27,668 | 14,174 | ||||||
| 合同责任 |
1,586 | 1,184 | ||||||
| 应付账款和应计费用 |
75,268 | 94,566 | ||||||
| 其他负债 |
42,241 | 41,176 | ||||||
| 应交所得税 |
1,016 | 2,299 | ||||||
| 备用金 |
100,268 | 32,719 | ||||||
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| 248,047 | 186,118 | |||||||
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| 838,457 | 736,509 | |||||||
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| 总负债 |
1,191,103 | 971,284 | ||||||
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| 所有板块权益和负债总计 |
1,093,783 | 825,587 | ||||||
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