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ING Investment Office 4 maart 2020 Galapagos - Kansrijke ontwikkelpijplijn zorgt voor verbreding beleggingscase
Ik vind verbranden van 420 tot 450 miljoen euro een verkeerde bewoording , ik zou liever horen van investeringen tussen 420 en 450 miljoen euro dat klinkt veel positiever .
Incoming questions Galapagos is getting with the highest frequency from Analysts: Hieronder het antwoord dat we vorige week deelden met onze analisten. Hopelijk helpt dit. Dit zijn zeker moeilijke dagen voor alle bedrijven, inclusief in onze sector, maar we hopen dat de boodschap hieronder duidelijk maakt dat we een sterk business continuity plan hebben. Vriendelijke groeten, en dank voor uw vertrouwen, Sofie -------------------------------------We’ve had a few questions come in on our preparedness for the corona virus: In light of the COVID-19 outbreak, Galapagos has strong measures in place to help prevent spread of the virus and protect the health of our staff, while ensuring business continuity . Such measures include limiting non-essential travel, canceling all travel to high-risk areas, asking people in high-risk areas to work from home where possible, and reminding everyone of good hygiene practices. Our global and site business continuity plans, and appropriate recommended travel precautions and restrictions, are active and up to date. Our security practices are designed with both known and unknown risks in mind. Access to our facilities is highly secure and requires careful scheduling, compliance with entrance procedures, wearing the appropriate personal protective equipment, and following disinfection and sanitization practices. We also have specific visitor policies at our sites in order to minimize risk of exposure and business disruption. We have a business continuity plan for our non-clinical and clinical trials, including a pandemic response plan. This entails all parameters of the study including efficacy, safety, PK/PD, and drug supply, in order to ensure adequate guidance is provided to sites and mitigation measures are in place. To date, patient visits in our clinical trials have continued with minimal impact. Build-up of our commercial operations in the EU5 countries to prepare for potential launch continues well. Gilead’s IR stands ready to address any questions or concerns around manufacturing of filgotinib. As we continue to monitor the situation closely, we are confident that our procedures are robust and that our employees and facilities are sound and secure. At present, there is no impact on trial timelines. Our business continuity is successfully ensuring our routine site-based operations, as well as clinical trial operations, are sustained. Sofie van Gijsel Director Investor Relations
RBC Capital Markets Galapagos (Sector Perform) PT $157 RBC Capital Markets verhoogt het verkoopadvies voor Galapagos naar houden. RBC Capital Markets verlaagt het koersdoel van Galapagos naar $157 van $175. Het verkoopadvies van donderdag 20 februari 2020 wordt vervangen door een houdadvies.
KBC Securities Galapagos (Hold) PT EUR 189 Galapagos en Gilead hebben besloten de rekrutering van patiënten in de lopende Filgotinib-proeven te stoppen, in het licht van de COVID-19-uitbraak. Terwijl de lopende en geplande inleidingen worden uitgesteld, zullen de fase III-studies in ulceratieve colitis nog steeds in het tweede kwartaal van 2020 worden uitgelezen. Het nieuws heeft geen impact op het “Houden”-advies en 189 euro koersdoel van KBC Securities. Het pauzeren van de selectie van kandidaten voor een proef met Galapagos-geneesmiddel filgotinib, is een rationele stap om de veiligheid van patiënten te waarborgen , menen analisten van KBC Securities. Patiënten met ernstige ontstekingsaandoeningen gebruiken vaak middelen die hun immuunsysteem onderdrukken en zijn daarom vatbaarder voor het nieuwe coronavirus . De stap heeft gevolgen voor een aantal klinische tests met filgotinib. Naar verwachting zullen onder meer onderzoeken naar de bruikbaarheid van het middel bij de behandeling van de ziekte van Crohn, athritis psoriatica en de oogontsteking uveïtis en een test om te beoordelen of het gebruik van het middel veilig is voor de testikels vertraging oplopen .De marktvorsers vinden dat Galapagos relatief zwaar is getroffen in de correctie, maar blijven ook voorzichtig. Er staan resultaten op de rol van een aantal risicovolle fase 2-tests. KBC meent dat een negatief resultaat in de huidige uitdagende omstandigheden gevolgen kan hebben voor de manier waarop beleggers naar het aandeel kijken. KBC houdt daarom vast aan zijn hold-rating met een koersdoel van 189 euro.
Update on COVID-19 (22 March 2020) We decided to pause enrollment into the filgo trials (ex UC) in order to help protect patient safety. I firmly believe that we will weather this storm and come out stronger. We are more determined than ever in our unwavering ambition to bring innovation to patients. Stay safe Onno van de Stolpe CEOUpdated statement from CEO
Bryan Garnier & Co Galapagos (Buy) PT EUR 230 CLINICAL TRIALS AFFECTED BY THE CURRENT SITUATION Firstly, companies have made public statements (Galapagos, Eli Lilly) to say they are stopping recruitment of patients and new study starts. This may of course impact the length of some clinical development programmes by a few weeks or months. Most of them are saying that ongoing trials are continuing for patients who are already enrolled in the trials but obviously, there is legitimate questions about the quality of the follow-up although most of the trials are structured in such a way that if some data points are missing, there are approved and accepted methodologies per study design to fill the gap by extrapolating the data in-between two or three visits since it is not unusual in trials. It is fair to anticipate an increased patient drop-out rate however that may require the extension of the recruitment period and an increase in the number of patients to fulfil the statistical analysis. In most cases, we expect the situation to delay the processes by a few months. However, there could be cases where the trials are not fully recruited yet and with some losses to follow-up in chronic diseases with long treatment duration and here the delay could be longer, with potential financing issues.INTERACTIONS WITH REGULATORS ARE PROBABLY AFFECTED TOO The second aspect of the business that is potentially impacted by the current situation concerns interactions with the healthcare authorities. Here also, we have heard cases of cancellations of advisory committees for instance which is unlikely to mean a simplified regulatory process but more probably a delay until a new one can be scheduled. The EMA has stated quite clearly on its website that the measures implemented “do not impact EMA’s core activities related to the evaluation and supervision of medicines”. That said, if only because each approval requires a visit and inspection of the manufacturing site, we cannot see how it will be possible to approve new drugs in the current environment since travel is banned. Filing, acceptance of filing and work on documents are activities that should not suffer too much but the final part of the approval process does not seem able to work at a steady pace. This again should be appreciated on a case by case basis.What is the situation for biotechs? We have tried to contact all these companies. The feedback we have had has been very mixed in quality and in terms of the extent of answers provided.Our two favourites in a defensive mode GALAPAGOS BACK TO AN ATTRACTIVE ENTRY PRICE On Sunday, Galapagos announced that it had decided to pause recruitment for the filgotinib trials until further notice to help protect patient safety. Note above all that this does not impact the phase III SELECTION programme in ulcerative colitis the results of which are still expected in the second quarter of this year. However, no mention was made of the ongoing regulatory process for filgotinib. With a PDUFA date set for 17th July, the whole process could be affected by the ongoing outbreak. Even if our contacts with the company give us reason to believe that everything is going as planned, we estimate that a general shift in timeline could cost up to EUR15/share . To reflect the impact on the other filgo trials, we have already reviewed our central scenario, decreasing our FV from EUR235/share to EUR230/share. The heavy discount to FV therefore prompts us to adopt a Buy rating again (vs Neutral).
Dank WST. Hierbij het rapport van Bryan, Garnier & Co dd 25 maart. Galapagos va page 6.
Op pagina 4 van het rapport van Bryan, Garnier & Co staat het volgende te lezen: "That said, if only because each approval requires a visit and inspection of the manufacturing site , we cannot see how it will be possible to approve new drugs in the current environment since travel is banned." Deze constatering is leidend voor de verwachting, dat er misschien sprake zal zijn van vertraging bij de introductie van filgotinib. Mogelijk wordt hier impliciet verwezen naar FDA's Pre-Approval Inspection (PAI) programma. In de EU-regelgeving bestaat een dergelijke eis van voorafgaande inspectie echter niet. Vandaar ook dat EMA aangeeft geen enkel uitstel in de behandeling van registratie-aanvragen te verwachten. Zie voor de formele aspecten artikel 8 van de DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001, zoals dat thans geldt. De afgifte van de gevraagde toelatingsvergunning is op geen enkele wijze gekoppeld aan een productgebonden inspectie van de fabricagesite. De uitspraak van de analisten van BG&Co is dus op zijn best slechts ten dele waar (nog daargelaten of het ooit zover komt, omdat de FDA straks niet wil achterblijven bij EMA?).
Coronacrisis biedt nieuwe koopkans voor Galapagos 26/03/20 om 14:00 Bijgewerkt om 15:07Danny Reweghs Directeur strategie Inside Beleggen
Beursblik: Jefferies zet Galapagos op de kooplijst FONDS KOERS VERSCHIL VERSCHIL % BEURS Galapagos 163,80 0,00 0,00 % Euronext Amsterdam (ABM FN-Dow Jones) Jefferies heeft maandag het advies voor Galapagos verhoogd van Houden naar Kopen, maar stelde wel het koersdoel neerwaarts bij van 225,00 naar 210,00 euro. Analist Peter Welford zei optimistisch gestemd te zijn over de aanstaande data met betrekking tot filgotinib. Die zullen vermoedelijk aangeven dat er een breder commercieel potentieel is voor de behandeling, denkt de analist. Verder wees Welford erop dat de kaspositie van Galapagos inmiddels goed is voor ongeveer 54 procent van de aandelenkoers. Dat betekent ook dat de piekverkoop voor filgotinib op "slechts" 2 miljard dollar wordt geschat. Dit in combinatie met de vermoedelijke zeer waarschijnlijke goedkeuringen voor filgotinib voor reumatoïde artritis en de ziekte van Crohn maakte dat Jefferies een koopadvies afgaf. Het aandeel Galapagos sloot vrijdag op 163,80 euro. Door: ABM Financial News.info@abmfn.nl Redactie: +31(0)20 26 28 999 © Copyright ABM Financial News B.V. All rights reserved.
Jefferies 30 maart 2020Upgrade to Buy; Upcoming SELECTION Should Underpin Filgotinib's Broad Potential PT naar EUR €210.00 (van €225.00)
Jefferies mbt Gilead 29 maart 2020Gilead Sciences Phase III Filgotinib UC Data Coming - Yes Other Stuff Besides Coronavirus Too
Degroof Petercam 31 maart 2020Galapagos (Buy from Hold) - Valuation update following corona pandemic (EUR 174.45 / TP EUR 215 from EUR 185) Facts – Stock hit hard by Covid-19 The coronavirus pandemic outbreak led to a massive sell off in financial markets. The healthcare industry was not spared from the hit, leading to substantial stock price declines, from small caps all the way to big pharma companies. Prior to this correction, we communicated on Galapagos’ share price having surged massively over the preceding 4 months. This occurred in absence of news that would have substantially affected valuation, in our view. The latter resulted in a peak share price of approximately EUR 250 in February. As massive as the surge was, so was the hit the stock took following the pandemic outbreak, being pushed down to levels as low as EUR 134, implying a value loss of more than EUR 7bn. We took the liberty to assess the company’s challenges, risks and strengths in view of the current uncertain, volatile period and performed a valuation update.Our view - Galapagos’ risks are industry-specific, its strengths are company-specific As for all biotech comps, Galapagos’ risk profile is mainly driven by the intrinsic risk of technical failure of its clinical assets, which we factor in our valuation by the attribution of success rates. Following the outbreak, the healthcare industry faces additional challenges, particularly clinical trial delays. Galapagos recently communicated on pausing enrollment of several filgotinib trials, including the Phase III trials in Crohn’s disease (CD), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The extent of these delays is hard to predict at this point. A unique strength of Galapagos is its blockbuster clinical asset filgotinib, which is currently in the registration phase for rheumatoid arthritis (RA) and set to start generating operational revenues in the near future. In addition, the Phase III readout in ulcerative colitis (UC) remains on schedule for 2Q20, which could imply a first label extension in 2021. In our view, filgotinib holds best-in-class potential for RA, UC, CD, PsA and AS. In this regard, we lowered our WACC for these programs from 12% to 10%, which is in line with industry peers. Last but not least, a key - if not the most crucial - strength of the company is its extremely solid cash position (EUR 5.8bn YE19). Not only does this allow intensifying (pre)clinical R&D efforts, it also eliminates the risk of potential financial distress in the near future, which could arise for other biotechs given that fundraising might prove to be very challenging during this period.Investment conclusion - An overstated correction providing a viable entry point In our view, the aforementioned strengths of the company outweigh its risks. Although the stock price surged towards illogical levels in February - leading to our downgrade in January - we believe the correction the company received has been overstated and now offers a viable entry point. Based on our updated input assumptions, we arrive at a TP of EUR 215 and therefore upgrade to a Buy rating. We await further clinical updates on the Phase III trial in UC in 2Q20, Phase II trials in idiopathic pulmonary fibrosis (IPF), systemic sclerosis (SSc) and osteoarthritis (OA) in 2H20 and the regulatory filing for filgotinib in RA in 2H20.
Thanks again for the update avantiavanti. Although I prefer the full report in PDF ;-)
Degroof Petercam Galapagos (Buy) PT EUR 215 31 March 2020 PDF File
Stifel update 8 april 2020 Rating: Buy TP 298$CEO Fireside Chat Recap: Maximizing Execution in COVID-19 Uncertainty; Filgo UC Data On-Deck; Broad Pipeline Progress
Dank Avantiavanti voor dit mooie rapport. Geeft veel vertrouwen! Management team Galapagos is vol vertrouwen voor goede data Colitis Ulcerosa. Voorsprong van zeker 2 jaar op RINVOQ binnen deze ziekte-indicatie is mijn veronderstelling. Daarbij heeft AbbVie nu haar marketing inspanningen RINVOQ voor RA gestopt. Er is voor Galapagos nog wel wat ruimte om naar $298 te groeien met veel aankomende data in komende maanden. Filgotinib > fase 3 data UC Filgotinib > approval RA (Japan, EU, USA) GLPG1690 > fase 2 data Ssc GLPG1972 > fase 2b data Artrose GLPG1205 > fase 2 data IPF TOLEDO > fase 1 data / 2a data.. Galapagos zal m.i. veel mooie data & voortgang etaleren in vervolg 2020!
RBC Capital Markets Galapagos (Sector Perform) PT $155 RBC Capital Markets verlaagt het koersdoel van Galapagos naar $155 van $157. Het houdadvies van maandag 6 april 2020 wordt herhaald.Equity Research Disclosures Risks to rating and price target (4/13/2020): Risks include significantly greater/less than expected uptake for filgotinib in RA, potential BD activity, and better/worse than expected clinical data for ’1690 in IPF, Toledo compounds in inflammatory disease, and/or ’1972 in osteoarthritis.Valuation (4/13/2020): Our $155 price target is derived from a DCF analysis of the base business with a 10% discount rate and 2.5% terminal growth rate. This valuation supports our Sector Perform rating.Sector Perform (SP): Returns expected to be in line with sector average over 12 months.
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