Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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: 001-34620 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3 ...

财务数据和关键指标变化 - 第三季度LINZESS美国净销售额为2.79亿美元,同比增长7%,主要由于处方需求增长8% [41] - LINZESS商业利润率为72%,去年同期为74% [41] - 公司第三季度营收为1.14亿美元,主要来自LINZESS美国合作收入1.10亿美元 [41] - 公司第三季度录得1800万美元所得税费用,大部分为非现金 [41] - 公司第三季度录得1000万美元利息费用和其他融资成本,获得200万美元利息投资收入 [41] - 公司第三季度GAAP净收益为1400万美元,调整后EBITDA为4900万美元 [41][42] - 公司第三季度经营活动产生约3300万美元现金流,第三季度末现金及等价物为1.10亿美元 [42] 各条业务线数据和关键指标变化 - LINZESS新增处方同比增长16%,体现患者和医生持续选择LINZESS [35] - 公司正在推广LINZESS用于6-17岁儿童和青少年功能性便秘,这是一个约600万患者的新市场机会 [36][37] 各个市场数据和关键指标变化 - 无相关内容 公司战略和发展方向及行业竞争 - 公司通过收购VectivBio拓展了短肠综合征业务,apraglutide有望达到10亿美元峰值销售 [8] - apraglutide在短肠综合征伴肠内失代偿患者(包括结肠连续性患者)的52周临床数据显示疗效持久,为公司STAR III期临床试验增添信心 [9][10] - CNP-104有望成为首个针对原发性胆汁性胆管炎根本原因的潜在疾病修饰疗法 [11][28][29] - IW-3300为公司自主研发的膀胱疼痛综合征潜在治疗药物,填补了该领域的重大未满足需求 [31] - 公司正在整合VectivBio业务,确保业务连续性并推进apraglutide临床开发 [39][40] 管理层对经营环境和未来前景的评论 - 公司对LINZESS未来增长前景充满信心,并看好apraglutide等管线项目的发展潜力,相信将推动公司进入新的增长阶段 [7][14][15] - 公司期待2024年关键临床数据的公布,包括apraglutide III期试验和CNP-104 II期试验结果,将为公司未来发展奠定基础 [33] 问答环节重要的提问和回答 问题1 **Jason Butler 提问** 1. LINZESS儿童适应症批准对第三季度业绩有何影响,以及对第四季度的预期 [50] 2. apraglutide改善肠道自主性如何影响定价和报销 [51] 3. CNP-104 T细胞反应的幅度如何,对临床结果的预测价值如何 [52] **Sravan Emany 回答** 1. 2023年全年指引已包含儿童适应症的影响,2023年贡献有限,将在2024年初给出更多指引 [54][55] 2. 减少对静脉营养支持的依赖对患者和经济负担都有重大改善,有望提供更好的临床价值主张 [56][57][58] **Mike Shetzline 回答** 3. 早期T细胞数据显示有利反应,支持CNP-104的作用机制,但这只是小规模非盲评估,需要等待II期完整数据结果 [59][60] 问题2 **David Amsellem 提问** 1. 结肠连续性(CIC)患者群体相对于造口患者群体的规模 [63] 2. Gattex目前的患者人群规模及周转情况 [63] 3. 如何考虑apraglutide的定价,假设Gattex出现仿制药 [63] **Sravan Emany 回答** 1. 全球短肠综合征患者约17,000人,CIC和造口患者各占约50% [66] 2. 美国约有2,000名Gattex患者 [67] 3. Gattex已有一定定价基准,我们将提供更有竞争力的临床数据组合,同时仿制药进入的可能性较低 [68][69] **Tom McCourt 补充** 3. Gattex患者中约50%在首年内停药,反映了该药的局限性,apraglutide从每日注射到每周注射,且更强效持久,有望惠及更广泛的CIC患者群体 [70] 问题3 **Boris Peaker 提问** 1. 为何不披露CNP-104的T细胞数据,何时会公布 [74] 2. Zelanepaglutide显示14%患者实现肠道自主性,对apraglutide数据的重要性 [74] **Sravan Emany 回答** 1. 计划在2024年三季度完成II期试验并公布完整数据结果 [75] **Mike Shetzline 回答** 2. apraglutide营养研究也显示部分患者实现肠道自主性,但规模较Zelanepaglutide小,III期数据将更好定义这一结果 [78]

Ironwood Q3 2023 Investor Update Safe Harbor Statement This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our ability to execute on our vision; our strategy, business, financial position and operations, including with respect to our strategic priorities; the demand, development, commercial availability and commercial potential of linaclotide and the drivers, timing, impact and results ther ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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: 001-34620 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-340417 ...

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) Q2 2023 Earnings Call Transcript August 8, 2023 8:30 AM ET Company Participants Matt Roache - Director of Investor Relations Tom McCourt - Chief Executive Officer Sravan Emany - Chief Financial Officer Mike Shetzline - Chief Medical Officer Andrew Davis - Chief Business Officer Conference Call Participants Tim Chiang - Capital One Boris Peaker - Cowen David Amsellem - Piper Sandler Operator Ladies and gentlemen, thank you for standing by. My name is Sharell and I ...

Creating Value for GI Patients and Shareholders Acquisition of VectivBio May 22, 2023 Safe Harbor Statement Certain statements in this communication may constitute "forward-looking statements". Forward-looking statements may be typically identified by such words as "may," "will," "could," "should," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions. These forward-looking statements are subject to known and unknown risks and uncertainties that ...

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) Q1 2023 Results Conference Call May 4, 2023 8:30 AM ET Company Participants Matt Roache - Director of Investor Relations Tom McCourt - CEO Mike Shetzline - Chief Medical Officer Sravan Emany - Chief Financial Officer Conference Call Participants Tim Chiang - Capital One Boris Peaker - Cowen Jacob Hughes - Wells Fargo Securities Operator Good day, and welcome to the Ironwood Pharmaceuticals Q1 2023 Investor Update Conference Call. Today's call is being recorded [O ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-34620 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-34041 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 001-34620 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3404176 (St ...

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) Q4 2022 Earnings Conference Call February 16, 2023 8:30 AM ET Company Participants Matt Roache - Director, IR Thomas McCourt - CEO & Director Michael Shetzline - Chief Medical Officer, SVP and Head, Research & Drug Development Sravan Emany - SVP, Principal Financial Officer & CFO Conference Call Participants David Amsellem - Piper Sandler & Co. Daniel Wolle - JPMorgan Chase & Co. Timothy Chiang - Capital One Securities Boris Peaker - Cowen and Company Operator Go ...