Elevidys因急性肝衰竭导致第二例死亡引发临床/监管/商业担忧

Restricted - External First LookROG.S/ROG SWEuropean Pharmaceuticals& Life SciencesPrice TargetPrice (13-Jun-25)Potential Upside/DownsideSource: Bloomberg, Barclays ResearchEuropean Pharmaceuticals & LifeSciencesEmily Field, CFA+44 (0)20 7773 6263emily.field@barclays.comBarclays, UKShirley Chen, PhD+44 (0)20 7773 2109shirley.chen@barclays.comBarclays, UKYihan Li, PhD+44 (0)20 3555 3563yihan.li@barclays.comBarclays, UKSidhartha Modi+91 (0)22 6175 1326sidhartha.modi@barclays.comBarclays, UKCharles Pitman-King, CFA+44 (0)20 3134 6023charles.pitman-king@barclays.comBarclays, UKAnurag Surendra Sharma+91 (0)22 6175 4548anuragsu.sharma@barclays.comBarclays, UK EQUAL WEIGHTNEUTRALCHF 275.00CHF 269.70+2.0% commercialise the drug in territories ex-US in 2019. Though EMBARK did not meet the primaryendpoint (see:Roche: EMBARK does not meet primary endpoint (31/10/23)), the drug was grantedUS full approval for ambulatory patients in Jun '24 based on functional benefits (see:SRPT -Elevidys label expansion home run...(20/06/24)).Roche has submitted the EU filing inambulatory DMD patients aged 4-7 years, and expects potential approval in 2025;however, we are conservative on its potential approval in EU.Elevidys has also beenapproved by regulatory authorities in eight Roche territories for the treatment of DMD includingBahrain, Brazil, Israel, Japan, Kuwait, Oman, Qatar, and the UAE.2 Analyst(s) Certification(s):I, Emily Field, CFA, hereby certify (1) that the views expressed in this research report accurately reflect my personal views about any or all of the subjectsecurities or issuers referred to in this research report and (2) no part of my compensation was, is or will be directly or indirectly related to the specificrecommendations or views expressed in this research report.Important Disclosures:Barclays Research is produced by the Investment Bank of Barclays Bank PLC and itsaffiliates(collectively and each individually, "Barclays"). Allauthors contributing to this research report are Research Analysts unless otherwise indicated. The publication date at the top of the report reflects thelocal time where the report was produced and maydifferfrom the release date provided in GMT.Availability of Disclosures:Where any companies are the subject of this research report, for current important disclosures regarding those companies please refer to https://publicresearch.barclays.com or alternatively send a written request to: Barclays Research Compliance, 745 Seventh Avenue, 13th Floor, New York, NY10019 or call +1-212-526-1072.The analysts responsible for preparing this research report have received compensation based upon various factors including the firm's total revenues,a portion of which is generated by investment banking activities, the profitability and revenues of the Markets business and the potential interest of thefirm's investing clients in research with respect to the asset class covered by the analyst.Research analysts employed outside the US byaffiliatesof Barclays Capital Inc. are not registered/qualified as research analysts with FINRA. Such non-US research analysts may not be associated persons of Barclays Capital Inc., which is a FINRA member, and therefore may not be subject to FINRA Rule2241 restrictions on communications with a subject company, public appearances and trading securities held by a research analyst’s account.Analysts regularly conduct site visits to view the material operations of covered companies, but Barclays policy prohibits them from accepting paymentor reimbursement by any covered company of their travel expenses for such visits.Barclays Research Department produces various types of research including, but not limited to, fundamental analysis, equity-linked analysis,quantitative analysis, and trade ideas. Recommendations contained in one type of Barclays Research maydifferfrom those contained in other types ofBarclays Research, whether as a result ofdifferingtime horizons, methodologies, or otherwise.In order to access Barclays Statement regarding Research Dissemination Policies and Procedures, please refer to https://publicresearch.barclays.com/S/RD.htm. In order to access Barclays Research Conflict Management Policy Statement, please refer to: https://publicresearch.barclays.com/S/CM.htm.Primary Stocks (Ticker, Date, Price)Roche(ROG.S, 13-Jun-2025, CHF 269.70), Equal Weight/Neutral, A/D/E/J/K/L/M/NUnless otherwise indicated, prices are sourced from Bloomberg and reflect the closing price in the relevant trading market, which may not be the lastavailable closing price at the time of publication.Disclosure Legend:A:Barclays Bank PLC and/or anaffiliatehas been lead manager or co-lead manager of a publicly disclosedofferof securities of the issuer in theprevious 12 months.B:An employee or non-executive director of Barclays PLC is a director of this issuer.CD:Barclays Bank PLC and/or anaffiliateis a market-maker in debt securities issued by this issuer.CE:Barclays Bank PLC and/or anaf