Analyst reports 2018

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avantiavanti
7
JP Morgan 26 oktober 2018

Galapagos NV
Model update post 3Q'18 results and R&D day


deel 1
Bijlage:
avantiavanti
5
avantiavanti
3

JP Morgan refereert in alinea 'Model updated for 3Q'18 and restructuring of the CF franchise naar deze update van 25 oktober jl.

Solid Q3. Restructuring of Cystic Fibrosis collaboration removes an overhang and frees up cash to invest in the pipeline
Bijlage:
Rrrenderen
0
quote:

avantiavanti schreef op 26 oktober 2018 10:09:



JP Morgan refereert in alinea 'Model updated for 3Q'18 and restructuring of the CF franchise naar deze update van 25 oktober jl.

Solid Q3. Restructuring of Cystic Fibrosis collaboration removes an overhang and frees up cash to invest in the pipeline


While many investors had already taken the value of the CF
portfolio out of models following the PELICAN trial, we believe there was some concern GLPG
would obtain full rights from AbbVie leading to significant R&D spend on a potentially
uncompetitive programme. Therefore we see the restructuring of the agreement as a positive and
believe the shares could be up c.2-3% this morning as the CF overhang is removed.

Tja, daar ging ik ook wel van uit; een lichte stijging. In plaats daarvan kregen we een daling van 4%.
avantiavanti
3
Nomura Instinet 30 oktober 2018

3Q Earnings – Raising TP to $140/sh
R&D Day Reveals Refocused, High-Value Pipeline


deel 1
Bijlage:
lmr
0
quote:

avantiavanti schreef op 31 oktober 2018 17:32:


Nomura Instinet 30 oktober 2018

3Q Earnings – Raising TP to $140/sh
R&D Day Reveals Refocused, High-Value Pipeline


deel 1


Ze houden in de 140 dollar prijs nog geen rekening met MOR106 of GLPG1972 inkomsten. Dus bij kans op waarde creatie vanuit deze onderdelen gaat het koersdoel omhoog.
Voor RA (Finch studies) houden ze rekening met een risico van 20% op falen. Mijn inziens is dit wat aan de hoge kant, zelf zou ik eerder rekenen met 10% zoals Onno zelf ook aangeeft geeft het zich al lange tijd bewezen voor veel patiënten.

Daarnaast lees ik dat ze filgotinib RA launch pas verwachten in de tweede helft van 2020. Afhankelijk van hoe snel Manta afgerond kan worden is hier wellicht nog wat ruimte te behalen. Wellicht begin 2020 in combinatie met een snelle afhandeling van de autoriteiten i.c.m. een ticket.
Topperke
0
Galapagos (advies KBC Securities: "Kopen" - koersdoel 113,00 euro)
NIEUWS | Galapagos kondigt de eerste dosering in de PINTA fase II-studie aan, een studie bij 60 patiënten die de werkzaamheid van het middel GLPG1205 moet aantonen bij idiopathische longfibrose (IPF). Het onderzoek loopt in 10 Europese landen, Noord-Afrika en het Midden-Oosten.
De mening van KBC Securities: Galapagos zet een nieuwe stap in zijn IPF-franchise, met GLPG1205 als tweede middel dat de fase II ingaat. De FLORA fase IIb-studie met GLPG1690, een autotaxineremmer, werd in augustus vorig jaar beëindigd en zal nu verder worden ontwikkeld in twee wereldwijde fase III-studies met 1.500 patiënten, onder de noemer ISABELLA 1 en 2. Het derde IPF-middel GLPG3499 zit momenteel in de pre-klinische ontwikkelingsfase, met als doel voor eind dit jaar een fase I aan te vatten. Zo beschikt Galapagos over drie middelen, elk met hun eigen werkingsmechanisme. Analiste Sandra Cauwenberghs wijst erop dat de IPF-franchise 23% van de som-der-delen-waardering vertegenwoordigt, naast Filgotinib (43%) en de cashreserves (27%). De investment case wordt bevestigd.

Dus 10% vd waarde werd toegekend aan GLPG1972, Toledo en Mor106.
Interessant om te zien. Hier is nog enorm veel upside. (1972 en Toledo zijn producten met meer potentieel dan Filgo)

avantiavanti
10
Raymond James 14 november 2018

Initiating at Strong Buy ($157 Price Target): Filgotinib Emerging as Bestin-Class Recommendation: We initiate coverage of Galapagos (GLPG) with a Strong Buy rating and a $157 12-month price target. Galapagos is a clinical stage biopharma company with a lead drug, filgotinib, which could be approved as a disease modifying drug for multiple auto-immune disorders, beginning with an U.S. FDA approval for the treatment of rheumatoid arthritis during 2020. Our investment thesis is based upon three key points, 1) filgotinib has demonstrated a clear path to approval across multiple indications, supporting our forecast for ~$2.9B in global drug sales during 2023E, 2) clinical data for filgotinib has steadily built evidence that it could be a best-in-class JAK inhibitor, and 3) the Galapagos pipeline of wholly owned therapeutic candidates is expected to rapidly expand over the next several years.

Deel 1

Bijlage:
jodu
1
quote:

avantiavanti schreef op 15 november 2018 09:19:


Raymond James 14 november 2018

Initiating at Strong Buy ($157 Price Target): Filgotinib Emerging as Bestin-Class Recommendation: We initiate coverage of Galapagos (GLPG) with a Strong Buy rating and a $157 12-month price target. Galapagos is a clinical stage biopharma company with a lead drug, filgotinib, which could be approved as a disease modifying drug for multiple auto-immune disorders, beginning with an U.S. FDA approval for the treatment of rheumatoid arthritis during 2020. Our investment thesis is based upon three key points, 1) filgotinib has demonstrated a clear path to approval across multiple indications, supporting our forecast for ~$2.9B in global drug sales during 2023E, 2) clinical data for filgotinib has steadily built evidence that it could be a best-in-class JAK inhibitor, and 3) the Galapagos pipeline of wholly owned therapeutic candidates is expected to rapidly expand over the next several years.

Deel 1




Top! Raymond James ziet in een bullish scenario zelfs een waardering tot $318 :)
[verwijderd]
0
Interessant rapport, flinke jongen ook Raymond James. Persoonlijk niet eerder van gehoord.
Valt mij op dat het base scenario van $157 en het bull van $318 eigenlijk alleen over Filgo en IPF gaan, met in mijn ogen behoorlijk conservatieve sales schattingen voor 1690.

Verder nog geen Mor106, 1972, Toledo verwerkt in de ramingen. Kan volgend jaar dus nog omhoog bij phase 2 resultaten IGUANA en Novartis die verder wil uitbreiden in andere ziektedomeinen. En ook als Toledo meer in de picture komt.

Verder ook geen woord over overnamespeculatie of Gilead.

De markt is nog niet overtuigd, maar de investment bankers steeds meer. Koersdoelen worden opgeschroefd. Volgens mij gaat het helemaal los in 2019.
voda
0
Galapagos forse outperformer in Europese biotechnologiesector
13 november 2018

Het aandeel Galapagos had de laatste jaren een sterk positief koersmomentum. Het aandeel was de afgelopen 5 jaar met een rendement van 543 procent één van de grote outperformers van haar sector. De sector leverde de voorbije 5 jaar een winst op van circa 237 procent. Overige outperformende aandelen in de sector zijn onder andere Pharming Assembly Biosciences en Catalyst Pharmaceutical Partners. Bij de sectorwinnaars zitten onder andere Pharming , Assembly Biosciences en Catalyst Pharmaceutical Partners.

Voor veel meer, zie link:

www.analist.nl/berichten/186816-galap...
avantiavanti
14
Morgan Stanley 27 november 2018

Galapagos NV (GLPG.O)
Bus Trip and IPF Symposium Takeaways


Stock Rating Overweight
Price Target $131.00

We hosted investors in a meeting with Galapagos mgt. in the company's office in Basel, Switzerland, following which we attended a symposium the company coordinated on idiopathic pulmonary fibrosis (IPF) and their efforts in the space. Overall, we believe these discussions helped clarify mgt.'s key considerations regarding next steps with filgotinib, outlined the opportunity/unmet need in IPF, and provided further detail on ISABELA trial design. We provide key takeaways from both events below.

Mgt. meeting takeaways (CEO Onno van de Stolpe and CMO Walid Abi-Saab): The discussion with mgt. covered several aspects of the company's pipeline, but focused primarily on filgotinib and GLPG1690 in IPF.

Filgotinib: (1) Regarding the MANTA male toxicity study for filgotinib, mgt. clarified that regulators in Japan have not asked for data from this study for filgotinib regulatory filings, that discussions are needed with regulators in the EU to better understand their requirements, and that the FDA does want the data from MANTA included in filgotinib U.S. regulatory submissions; (2) Mgt. noted that the MANTA study is being conducted in ulcerative colitis (UC) patients because the FDA was concerned about the risk/benefit of JAK inhibitors in healthy volunteers; (3) Mgt. anticipates that there will eventually be ~200 patients on drug in the MANTA study, and the company plans to discuss further specifics regarding the FDA's stance on MANTA and regulatory submissions once data from the PhIII FINCH1 and FINCH3 studies of filgotinib in RA are available in early 2019; (4) Mgt. believes that the FINCH1 data will be important, and that filgotinib will have to demonstrate superiority to Humira in this study in order to match the data generated by AbbVie's oral JAK inhibitor upadacitinib (AbbVie is covered by David Risinger); (5) Mgt. does not see a promising risk/reward profile for oral JAK inhibitors in addressing atopic dermatitis (AD), as recently approved agents as well as selective agents under development (including IL-17C antibody MOR106) will not leave enough of an unmet need to warrant the use of global immunosuppression.

IPF: (1) Mgt. estimates that there are ~80K new patients with IPF every year, and that the market opportunity is multiple fold greater than the ~$2B in sales currently generated by the two approved therapies (pirfenidone and nintedanib); (2) IPF patients experience a yearly FVC loss of ~250 mL/year when untreated, and a loss of ~125 mL/year when treated with current SOC; (3) The two PhIII ISABELA studies of GLPG1690 in IPF are powered to detect an 80 mL FVC difference vs. placebo. Mgt. noted that an 80 mL separation was targeted based on clinician input that this improvement level would be clinically meaningful; (4) Patients in ISABELA will be stratified by their current SOC, as either pirfenidone (1/3 of patients), nintedanib (1/3), or no treatment (1/3); (5) Mgt. clarified that while the ISABELA SAP includes pooled data across both studies, the primary endpoint is change in FVC at 1 year in each of the studies. Therefore, if one study were to fail, all pooled data would technically become exploratory; (6) GLPG1690 is not being evaluated in patients refractory to SOC drugs because mgt. believes GLPG1690's safety profile is better than that of pirfenidone and nintedanib, and therefore GLPG1690 should not be relegated to a second-line position assuming positive efficacy data; (7) The PhII PINTA study of GLPG1205 in IPF is recruiting patients in different countries from the ISABELA program, and mgt. estimates that 50% of patients recruited will be on background therapy whereas 50% will not. This is different than the ‘1690 PhII study where no patients were on background therapy.

IIPF symposium: The symposium included an IPF disease overview, a GLPG1690 status update, a discussion on the role of mesenchymal stem cells in fibrosis, and a look into Galapagos' preclinical fibrosis discovery efforts. Key takeaways include: (1) The incidence of IPF in the U.K. has increased from ~2.5K cases/year in 1990 to ~6K cases/year in 2010, and ~1/100 deaths in the U.K. is now attributed to IPF; (2) An average patient loses 10% of their lung function every 12 months, and lost lung function is never gained back. Median untreated survival time is ~3 years post diagnosis; (3) IPF patients who experience an acute exacerbation die in a median of 30 days following the exacerbation episode; (4) Approximately 20% of patients cannot take currently approved drugs due to their poor side effect profiles, and lung transplants - while they can be effective - are only viable for a small portion of patients (~350 performed every year in the U.K., versus an IPF incidence of ~6K cases); (5) The first patient has been screened in ISABELA, and both studies are ready for enrollment; (6) While the work cited is highly preliminary, early data suggests that lung-resident stem cell derived conditioned medium reverses the pathology of fibrosis; (7) In its preclinical discovery efforts in fibrosis, the company is studying the MKL1 pathway, which the company believes is a central pathway in fibrosis. Systemic sclerosis and NASH were highlighted as two areas where Galapagos aims to further its efforts.
avantiavanti
16
Kempen

Rating BUY
Price Target €125.00
Closing price (26 Nov 2018 )€88.04

Galapagos - IPF symposium takeways

European Life Sciences 27 November 2018, 08:46
We have attended IPF symposium hosted by Galapagos in its new Basel
office that covered the treatment paradigm and unmet medical need in the
IPF space and reiterated Galapagos' commitment to fibrosis research and
its differentiated drug development approach in the space, as exemplified
by a unique MOA for GLPG1690 and follow-on compounds.

Key takeaways:

Differentiated MOA for GLPG1690. GLPG1690 has a unique mechanism
of action (MOA) inhibiting both production of LPA and its trafficking
to the cell surface, thus providing a deeper effect on the LPA
pathway in fibrosis, which potentially explains efficacy in the phase
II and differentiates GLPG1690 from other autotaxin inhibitors in the
development. Furthermore, it was reiterated that while GLPG1690 does not
act on the TGF-b pathway (it is probably best not, due to its involvement
in other functions), GLPG1690 potently reduces the downstream signaling
through IL-6, EMT and CTGF (also targeted by pamrevlumab), with
the effect enhanced by the combination with nintedanib. The latter also
demonstrates that GLPG1690 has a different and synergistic MOA with
nintedanib, which reads positive for the phase III trials.

Phase III ISABELAs are on its way. There are ~11 mid-late stage trials
in IPF ongoing at the moment, including ISABELAs 1 and 2, that together
post the demand for ~3500 IPF patients. According to Galapagos’ CMO,
while it makes it harder to predict recruitment timelines for ISABELAs, a
headstart against competition (Prometic has not started yet, Fibrogen is
going for the second line) and broader inclusion criteria compared to the
initial registration trials with pirfenidone and nintedanib should facilitate
recruitment. As a reminder, twin ISABELLA trials evaluate 600mg/200mg
GLPG1690 on top of standard of care (pirfenidone, nintedanib or neither)
vs. SOC till the last patient completes 52w treatment. The primary endpoint
is FVC and trials are powered to demonstrate ~80ml difference in FVC,
a clinically meaningful effect. The trials will also have an interim analysis
when 25% of patients complete treatment.

GLPG1690 is only the beginning. Fibrosis research is core to Galapagos
and there are multiple programs to explore GLPG1690 in other fibrosis
indications (e.g. phase II in systemic sclerosis to start before YE'18) as well
as new candidates targeting fibrosis outside of the TGF-b pathway (e.g.
GLPG3499 acting through mlk1 - fibrosis specific target) selected based
on proprietary fibrotic assays.
aston.martin
7

Andermaal een AB, avantiavanti

Dit verslag van Kempen n.a.v. het IPF symposium is trouwens nog veel informatiever dan dat van Mogan Stanley.
Kempen meldt bijvoorbeeld ook de start van een nieuwe POC studie met 1690 in systemische sclerose.


Systemic Sclerosis (SS)
Systemic sclerosis (SS) is an autoimmune disorder. This means it’s a condition in which the immune system attacks the body. Healthy tissue is destroyed because the immune system mistakenly thinks it’s a foreign substance or infection. There are many kinds of autoimmune disorders that can affect different body systems.

SS is characterized by changes in the texture and appearance of the skin. This is due to increased collagen production. Collagen is a component of connective tissue.

But the disorder isn’t confined to skin changes. It can affect your:

blood vessels
muscles
heart
digestive system
lungs
kidneys
Features of systemic sclerosis can appear in other autoimmune disorders. When this occurs, it’s called a mixed connective disorder.

The disease is typically seen in people 30 to 50 years old, but it can be diagnosed at any age. Women are more likely than men to be diagnosed with this condition. The symptoms and severity of the condition vary from one person to another based on the systems and organs involved.

Systemic sclerosis is also called scleroderma, progressive systemic sclerosis, or CREST syndrome. “CREST” stands for:

calcinosis
Raynaud’s phenomenon
esophageal dysmotility
sclerodactyly
telangiectasia
CREST syndrome is a limited form of the disorder.

www.healthline.com/health/scleroderma

www.uzleuven.be/nl/systeemsclerose


maxen
6
Weer interessant leesvoer Avantiavanti!

Deze wilde ik even uitlichten:
quote:

avantiavanti schreef op 27 november 2018 09:49:


Kempen
...
Phase III ISABELAs are on its way.
...
The trials will also have an interim analysis
when 25% of patients complete treatment.

Ruwweg 1/3 van de patienten in de Isabela trials zijn aan 1690 dose A, 1/3 aan dose B, en 1/3 aan placebo (dit alles bovenop wat ze al namen, te weten pirfenidone of nintedanib, of niets).

De voorgaande, beloftevolle studie met GLPG1690 in IPF had slechts 23 deelnemers. Op basis daarvan is er dus nog een redelijk grote onzekerheid over de werkzaamheid en eventuele bijwerkingen.

Isabela 1 en 2 gaan over veel grotere aantallen: 2 x 750 = 1500 deelnemers.
De interim analysis zal dus worden gehouden bij 25% x 1500 = 375 deelnemers, alsnog meer dan 15x zoveel als bij de eerste trial.

Als nu bij deze interim analysis zou blijken dat 1690 niet/nauwelijks werkt en/of zeer ernstige bijwerkingen zou hebben, zou voortijdig de stekker uit de Isabela trials kunnen gehaald worden.

Maar wellicht zou het ook kunnen dat de supergoede resultaten uit de eerste trial bevestigd worden, en dat er met 1690 niet/nauwelijks achteruitgang in longfunctie meer is, of zelfs enig herstel. In dat geval zou er wellicht besloten kunnen worden dat het vanuit ethisch perspectief niet meer houdbaar is om de placebo patienten te laten lijden, en per direct alle patienten op 1690 te zetten. Dat zou natuurlijk een grote boost betekenen voor 1690 en Galapagos, lang voordat de Isabela trials be-eindigd zijn.
harvester
1
quote:

maxen schreef op 27 november 2018 12:17:


Weer interessant leesvoer Avantiavanti!

Deze wilde ik even uitlichten:
[...]
Ruwweg 1/3 van de patienten in de Isabela trials zijn aan 1690 dose A, 1/3 aan dose B, en 1/3 aan placebo (dit alles bovenop wat ze al namen, te weten pirfenidone of nintedanib, of niets).

De voorgaande, beloftevolle studie met GLPG1690 in IPF had slechts 23 deelnemers. Op basis daarvan is er dus nog een redelijk grote onzekerheid over de werkzaamheid en eventuele bijwerkingen.

Isabela 1 en 2 gaan over veel grotere aantallen: 2 x 750 = 1500 deelnemers.
De interim analysis zal dus worden gehouden bij 25% x 1500 = 375 deelnemers, alsnog meer dan 15x zoveel als bij de eerste trial.

Als nu bij deze interim analysis zou blijken dat 1690 niet/nauwelijks werkt en/of zeer ernstige bijwerkingen zou hebben, zou voortijdig de stekker uit de Isabela trials kunnen gehaald worden.

Maar wellicht zou het ook kunnen dat de supergoede resultaten uit de eerste trial bevestigd worden, en dat er met 1690 niet/nauwelijks achteruitgang in longfunctie meer is, of zelfs enig herstel. In dat geval zou er wellicht besloten kunnen worden dat het vanuit ethisch perspectief niet meer houdbaar is om de placebo patienten te laten lijden, en per direct alle patienten op 1690 te zetten. Dat zou natuurlijk een grote boost betekenen voor 1690 en Galapagos, lang voordat de Isabela trials be-eindigd zijn.


Dan licht ik ook nog 2 punten uit:
Kempen:
GLPG1690 has a different and synergistic MOA with
nintedanib, which reads positive for the phase III trials.
Moran StAnley:
mgt. believes GLPG1690's safety profile is better than that of pirfenidone and nintedanib, and therefore GLPG1690 should not be relegated to a second-line position assuming positive efficacy data;


Daar lees ik uit:
wie nintedanib bijwerkingen kan verdragen heeft er baat bij om ook 1690 te gebruiken, naast nintedanib.
HansGarrincha
3
En mij valt ook dit op:
" Systemic sclerosis and NASH were highlighted as two areas where Galapagos aims to further its efforts."
NASH is een groot ziektedomein waar ook Gilead veel in heeft geinvesteerd (...). Er zijn al heel wat spelers in Ph. 3 studies daar (waaronder Genfit) en het lijkt erg competetief. De markt is wel erg groot en snel groeiende.
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