Egetis Therapeutics AB 2026 Q2财报电话会议纪要

发布时间：2026-08-21 一、AI总结内容 一、核心要点 1. 2026年第二季度运营数据：经营活动现金流为-9390万瑞典克朗，季度末现金储备达3.78亿瑞典克朗（约4000万美元）；成功完成3.5亿瑞典克朗定向增发，发行价无折价，获现有股东及新投资者强力认购。 2. 美国新药申请（NDA）进度：FDA已授予优先审评资格，审评截止日为2026年9月28日，无需召开咨询委员会；若获批，拟于2026年第四季度上市，患者扩张接入项目（EAP）已有60名患者入组（分布于17个美国位点）。 3. 其他关键进展：获美国专利商标局授权的首个专利，覆盖活性成分、治疗方法等，将列入橙皮书，2045年到期；任命Tiago Nunes为首席医疗官，负责EMPATE适应症扩展至抵抗型甲状腺激素β（RTHβ）的开发规划。 二、全球商业化进展 1. 欧洲市场：2026年第二季度营收1740万瑞典克朗，同比增长23%（固定汇率）、环比增长约30%；德国完成医保定价谈判，年均治疗成本预估低于20万欧元；西班牙提交医保申请，意大利、法国计划补充生存数据以完善价值论证；通过伙伴覆盖土耳其、中东欧、澳新等市场。 三、财务与管线风险及关注 1. 财务层面：第二季度净亏损1.093亿瑞典克朗，亏损扩大源于研发、行政投入；美国市场为核心优先级，需优先保障该区域商业化准备的资金支持。 2. 管线层面：RTHβ适应症开发尚处于规划阶段，待9月关键意见领袖科学咨询委员会后确定研究设计，拟利用EMPATE现有安全性数据简化审批；监管交互需保持紧密沟通，确保美国NDA审评无重大偏差；重点关注9月FDA审评结果、EMPATE过渡至商业化的患者治疗连续性、RTHβ开发路径确定进度。 二、音频原文（转写） For continued investments and the work with theu s and the a u s commercial love and corresponding preloons activitiesthe management the boardand our main shareholders are all a line that investing in the u s is a priority as we believe this will be by far our most important market andwhere we need to succeedfor the second quartercash flow from operating activities were at negative ninety three point nine million versus negative fifty nine million.Highlighted in the report with its strength in the cash position furtheron april twenty firstin total we did raise thre e hundred and fifty million corresponding to a thousand to eight million u s daughter on the gross spacesthe high demand for the shares offeredwere depicted by the fact that they were issuedat the shipprise of five point twenty five whichcorrespond to a zero per cent discountcoffee close the same day.With the cash from this transaction we ended the quarter with a healthy cash cash position of three hundred seventy eight millioncorrespond is approximity forty million us talk.With that i would like to han back to a nicholasthank your mosslet me summarizeand whilst reflectingfor the first two quarters in twenty twenty six it i am very proud to say that we have hadseveral key deliverables that has been with a very successful outcomelet me also remind you ofthe upcoming milestones from vegetis we have a padu for date set for the twenty eighth of september.Subsequently subject to approval we expect to launch and citate in the u s in quarter fourour most important marketalso worth while noting is being granted the priority review voucher uponapproval it is likely that monetization of sucha priority review voucher could take place in quarter fourof notice that p r v sold in twenty twenty six have fetch between one hundred and eighty and two hundred and twenty million u s dollars eachlast but not least the preparation of indication expansion into r t h vitaour next exciting pipeline opportunity is now progressing at pacewe are convening a scientific advisory board which the opinion leaders in the field to finalize the development program or empate in r t h beta and are in parallel preparing for regulatory interactions to agree the overall development pathway with the aim of starting a clinical study during twenty twenty sevenof notice that we haveto day over fifty patients with our page vita that are being treated with ampsitate as a part ofa managed access program.In summary we believethat a commercial opportunity here could be on p ower with one for empate efficiencywith thati'llhand over to the operator for q and a thank you.If you wish to ask the question please dial pound key five on your telephone keypad to enter the queue if you wish to withdraw your question please dial pound key six on your telephone keypadthe next question comes from kristen kluska fromcandor fitzgerald please go ahead.Hi good afternoon everybody and congrats on all of the problem over this last quarter while respecting you'restill very much in in active.Review with the fea can you give us any high level feedback on themid to late cycle meeting was there anything substantial that came up anything that surprised you for example.Thank you kristen and great to hear from you well in essence we as always don't communic communicate round ongoing regulatory interactions having said that though to give some more color as mentioned during the course being avery very constructive and productive dietreiterated that they will hold true to the perupidateset on the twenty eighth of september they arenot planning to hold an advisory committee and of course with respect to that if something wouldhave materially deviated with our entirethat would have been seen as material and subsequentlywe would have to notify the market nothing all in all internally we are very pleased with the dialogues with the agency so far and looking forward to the produce the late on the twenty eightokay i appreciate those comments thank you and then on the survival data. I know we could expect this perhaps in a peer review journal at some point but can you just remind us has the faa reviewed these data yet and and i know you can't comment on all of the findings justto hold it for