DUBLIN, Oct. 18, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist (LAMA), evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstruc ...

A month has gone by since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 2.2% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Theravance Bio due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Theravance's Q2 Loss Wider Than Expect ...

公司概况 - 公司主要专注于开发和商业化药物[98] - 公司开发了FDA批准的YUPELRI(revefenacin)吸入溶液,用于治疗慢性阻塞性肺病(COPD)[99] - 公司正在开发一种名为ampreloxetine的晚期研究阶段一次性每日诺肾上腺素再摄取抑制剂,用于治疗多系统萎缩(MSA)患者的症状性神经源性正位性低血压(nOH)[100,101] YUPELRI产品 - YUPELRI是一种每日一次的长效肌肉松弛剂(LAMA),被国际COPD治疗指南认为是COPD维持治疗的基石,公司研究发现有一个持久的COPD患者群体需要或更喜欢雾化给药[102] - 公司与Viatris公司合作开发和商业化YUPELRI,Viatris负责美国的商业化,公司获得35%的利润分成,在美国以外的地区公司获得低双位数至中低位数的特许权使用费[103,104] - 公司有望从Viatris获得最高2.05亿美元的全球开发、监管和销售里程碑付款,其中1.6亿美元与YUPELRI单药治疗相关,4500万美元与未来潜在的组合产品相关[105,106,107] - 公司有望从Viatris获得最高5250万美元的与在中国地区开发和商业化雾化revefenacin相关的里程碑付款,并有权获得14%-20%的特许权使用费[106,107,108,109] - YUPELRI 2024年上半年净销售额为1.098亿美元,同比增长8%,公司获得35%的收益份额[130] TRELEGY产品 - 公司完成了对Theravance Respiratory Company, LLC的全部股权权益的出售,获得约11.1亿美元现金[120] - 从2023年1月1日起,如果TRELEGY达到一定的最低特许权使用费金额,Royalty Pharma将有义务向公司支付特定的现金付款,最多2亿美元[121] - TRELEGY 2024年全球净销售额预计将达到约40亿美元,2023年全年全球净销售额为27.4亿美元,同比增长28%[122] - 公司将从Royalty Pharma获得TRELEGY在美国的销售特许权使用费,直至2032年底,在美国以外的地区的特许权使用费将持续到20年代中期[123] 成本管控 - 2024年上半年研发费用同比下降21%,主要由于2023年战略行动导致的研发投资减少[143] - 2024年上半年销售、一般及管理费用同比下降12%,主要由于2023年战略行动的影响[146] - 2024年第二季度和上半年股份支付费用分别为420万美元和800万美元,而2023年同期分别为440万美元和860万美元[149] - 2024年第二季度和上半年确认了295.1万美元的长期资产减值费用,而2023年同期没有[151][152]

Theravance Biopharma, Inc. (TBPH) reported a second-quarter 2024 adjusted net loss of 13 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 9 cents per share. In the year-ago quarter, the company had reported a loss of 13 cents per share. The reported loss excludes share-based compensation expense, non-cash impairment of long-lived assets, income tax expense and non-cash interest expense. Including these items, the company reported a loss of 34 cents per share in the second quar ...

Theravance Biopharma, Inc. (NASDAQ:TBPH) Q2 2024 Earnings Conference Call August 5, 2024 5:00 PM ET Company Participants Rick Winningham - Chief Executive Officer Aine Miller - Head, Development Rhonda Farnum - Chief Business Officer Aziz Sawaf - Chief Financial Officer Conference Call Participants Douglas Tsao - H.C. Wainright David Risinger - Leerink Partners Ernie Rodriguez - TD Cowen Liisa Bayko - Evercore ISI Operator Ladies and gentlemen, good afternoon. I would like to welcome everyone to the Therava ...

财务表现 - YUPELRI (revefenacin)净销售额为5450万美元,较2023年同期下降1%[4] - Viatris合作收入为1430万美元,较2023年同期增长4%[9] - 公司第二季度总收入为1.43亿美元，同比增长3.7%[40] - YUPELRI产品在第二季度的净销售额为5453万美元，公司享有35%的净利润份额为1909万美元[43] - 公司录得非GAAP净亏损625万美元[44] 研发和营销 - 预计2025年中期完成CYPRESS研究的最后一名患者入组,约6个月后获得顶线数据[7] - 研发费用为998万美元，销售及管理费用为1.71亿美元[41] 里程碑和特许权使用费 - Viatris已在中国提交YUPELRI新药申请,获批后可获得750万美元里程碑付款[3] - TRELEGY 2024年第二季度全球净销售额为10.65亿美元,增加了2024年实现最高5000万美元里程碑付款的可能性[8] - 公司未来或有里程碑和特许权使用费资产为1.942亿美元[37] 财务状况 - 2024年6月30日现金余额为9610万美元[15] - 预计2024年全年研发费用为3000万美元至3600万美元,销售及管理费用为4500万美元至5500万美元,不包括股份支付[16] - 预计2024年全年股份支付费用为1800万美元至2200万美元[18] - 预计2024年上半年水平的非公认会计准则净亏损和现金消耗将持续[19] - 公司现金及现金等价物为9.61亿美元[37] - 公司长期经营租赁负债为4.24亿美元[38] - 公司未确认税收利益为6.91亿美元[38] - 公司股东权益为1.94亿美元[38] - 公司预计未来无法在不付出不合理努力的情况下提供非GAAP净利润的前瞻性信息[35] 其他 - 公司正在探索通过税务和财务顾问来解锁价值的机会[20]

About Theravance Biopharma THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). DUBLIN, July 25, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 6 at 12:00 pm ET (9:00 am PT/5:00 pm IST). Members of Theravance Biopharma senior management will also be hosting one-on-one meeti ...

Conference Call Information A replay of the webcast will be available on Theravance Biopharma's website for 30 days through September 4, 2024. Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease ...

Prioritizing Resource Allocation Toward Ampreloxetine: Theravance is prioritizing the development of ampreloxetine, a norepinephrine reuptake inhibitor, for the treatment of symptomatic nOH in patients with MSA. The FDA has granted Orphan Drug designation to ampreloxetine for the treatment of symptomatic nOH in patients with MSA. Theravance has collaborated with Viatris (VTRS) for the commercialization of Yupelri, as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD) in the Un ...

Table of Contents Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36033 (Mark One) Cayman Islands 98-1226628 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organizatio ...