Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced the resubmission of its suppleme ...

MONTREAL, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today announced data from two poster presentations, focusing on the association between excess visceral abdominal fat (EVAF) and cardiovascular disease (CVD) risk in people with HIV (PWH), and on the use of tesamorelin to reduce such risk. In a poster presentation at IDWeek 2024 in ...

MONTREAL, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today disclosed the study design and baseline characteristics of participants in the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US). The study seeks to fill a critical gap in lo ...

财务数据和关键指标变化 - 第三季度收入为2260万美元,同比增长8.4% [9][21] - EGRIFTA SV收入为1670万美元,同比增长27% [22] - Trogarzo收入为590万美元,同比下降23.4% [23] - 毛利率方面,EGRIFTA SV为91%,Trogarzo为48% [23] - 调整后EBITDA为720万美元,同比增长227% [26] - 实现净利润300万美元,每股收益为0.06美元 [27] - 公司现金及等价物余额为3900万美元,净债务为2000万美元 [27] 各条业务线数据和关键指标变化 - EGRIFTA SV新患者注册、总独特患者数和销售单位同比均实现两位数增长 [10] - Trogarzo销售单位下降,主要受到多重耐药HIV-1市场竞争压力影响,但销售趋于稳定 [23] 各个市场数据和关键指标变化 - 公司主要聚焦于美国和加拿大市场 [39][40] 公司战略和发展方向及行业竞争 - 公司正在寻求收购或授权创新产品,以拓展产品组合,提升竞争力 [36][37][40] - 公司有能力在稀有或细分市场推广创新疗法,具有独特的价值主张 [19] - 公司正在推进F8型Tesamorelin的FDA再提交工作,预计2025年上市 [15][16] 管理层对经营环境和未来前景的评论 - EGRIFTA SV需求强劲,销售表现创历史新高 [10] - Trogarzo销售趋于稳定,不会进一步下降 [11] - EGRIFTA SV生产受到短期影响,但不会影响2024年患者供应 [12][14] - 公司有信心在2025年上半年弥补2024年第四季度的销售损失 [14] - 公司有望在2024年实现17-19百万美元的调整后EBITDA [13][27] 其他重要信息 - 公司正在推进sudocetaxel zendusortide的I期临床试验 [18] - 公司将在IDWeek会议上发表3篇关于EVAS、tesamorelin和ibalizumab的海报 [17] 问答环节重要的提问和回答 问题1 **Justin Walsh 提问** 询问EGRIFTA SV生产问题的整改情况及应对措施 [30][31][32][33] **Paul Levesque 和 John Leasure 回答** - 公司正与生产商密切沟通,制定全面的纠正措施计划并向FDA提交PAS申请 [31][32] - 公司有足够的库存可以满足到2025年1月中旬的患者需求 [32][33][34] 问题2 **Andre Uddin 提问** 询问公司未来产品拓展策略,是否会建立加拿大销售团队 [39][40] **Paul Levesque 回答** - 公司将关注美国和加拿大两大核心市场,根据需要建立销售团队 [40] - 公司将寻求有价值主张且能快速产生贡献的创新产品 [40] 问题3 **Carvey Leung 提问** 询问公司如何确保EBITDA和利润的可持续性,以及EGRIFTA SV在2025年的销售增长情况 [49][50][53][54] **Philippe Dubuc 和 John Leasure 回答** - 公司的成本结构已经优化到理想状态,未来收入增长将直接带动利润增长 [51][52] - EGRIFTA SV销售在2025年初可能会受到短期影响,但将在当季内完全弥补 [53][54]

文章核心观点 - 公司第三季度收入为2260万美元,同比增长8.4% [8] - EGRIFTA SV®销售额增长26.6%,Trogarzo®销售额下降22.9% [8][9] - 公司调整2024财年收入指引为83-85亿美元,调整EBITDA指引为17-19亿美元 [6] 财务数据总结 收入 - 第三季度收入2260万美元,同比增长8.4% [8] - 前9个月收入6.09亿美元,同比增长4.4% [8] - EGRIFTA SV®第三季度销售额1.67亿美元,同比增长26.6% [8] - Trogarzo®第三季度销售额591.3万美元,同比下降22.9% [9] 成本和费用 - 第三季度销售成本452.1万美元,同比下降9.0% [10][11] - 第三季度研发费用261.2万美元,同比下降51.6% [13] - 第三季度销售费用630.7万美元,同比下降6.3% [14] - 第三季度管理费用294.7万美元,同比下降20.5% [17] 利润 - 第三季度净利润309.1万美元,去年同期亏损746万美元 [22] - 前9个月净亏损403万美元,去年同期亏损2.12亿美元 [22] - 第三季度EBITDA723.9万美元,去年同期216万美元 [18] 其他重要信息 - 公司面临EGRIFTA SV®短期供应中断风险,正在采取措施应对 [4][26][27] - 公司正在推进F8配方和sudocetaxel zendusortide的研发 [3] - 公司正在寻求新的合作伙伴和产品 [3] - 公司流动性和持续经营存在不确定性,需要依赖贷款人的支持 [23][25][27][28]

MONTREAL, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today announced three upcoming poster presentations at IDWeek 2024, taking place October 16-19 in Los Angeles, Calif. One poster presents data linking excess visceral abdominal fat (EVAF) to increased cardiovascular risk in people with HIV, while a second poster documents how use o ...

MONTREAL, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced the Company will report financial results and provide a business update for its third quarter ended August 31, 2024, on Thursday, October 10 at 8:30 a.m. ET. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. He will be joined by o ...

MONTREAL, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced a risk of a temporary supply disruption for EGRIFTA SV® (tesamorelin for injection) in early 2025 caused by an unexpected voluntary shutdown of the Company's contract manufacturer's facility following an inspection by the US Food and Drug Administration (FDA), ...

文章核心观点 - 公司Theratechnologies是一家专注于开发和商业化创新疗法的生物制药公司 [1] - 公司的总裁兼首席执行官Paul Lévesque将在9月份参加两个投资者会议进行演讲,公司管理团队也将参加一对一会议 [2] 公司信息 - Theratechnologies是一家上市的生物制药公司,股票代码为TSX: TH和NASDAQ: THTX [1][3] - 公司专注于开发和商业化创新疗法,以满足未满足的医疗需求 [1][3] - 公司的网站、SEDAR+和EDGAR上都有更多信息 [3] - 公司在LinkedIn和X(原Twitter)上有官方账号 [3] 投资者和媒体联系方式 - 投资者咨询可联系公司高级副总裁兼首席财务官Philippe Dubuc [3] - 媒体咨询可联系公司高级沟通和公共事务总监Julie Schneiderman [3]

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