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Analyst reports 2018

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aston.martin
1
quote:

HansGarrincha schreef op 27 nov 2018 om 14:24:


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.



De competitie werd vandaag zelfs nog iets groter:

finance.yahoo.com/news/roche-buys-u-b...

Waarschijnlijk staan we hier nog maar in het begin van de evolutie.
Een beetje zoals bij IPF. Enkele jaren geleden kwamen de eerste producten op de markt: pifenidone en nintedanib. Ondertussen is de volgende generatie (hopelijk betere) producten in late ontwikkeling. We denken dan in de eerste plaats aan ‘1690.
Maar Galapagos zelf laat het ook daar niet bij en werkt zelf aan meerdere vervolgmoleculen.

Heel normaal dus in de farmawereld. Constant verbeteren. Veel spelers in ieder domein. Men is dus nooit alleen.
Tenzij voor enkele heel zeldzame ziekten dan.


avantiavanti
8
Bernstein 27 november 2018

Rating
Outperform
Target Price
GLPG.NA 122.00 EUR


Galapagos: Thoughts from the GLPG symposium on IPF - GLPG's
game changer waiting in the wings
Bijlage:
avantiavanti
10
Degroof Petercam 28 november


Galapagos (Buy) - FDA Fast Track designation for GLPG1972 in osteoarthritis (EUR 87 / TP EUR 125)



Facts – Accelerating GLPG1972 development

The FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA).

The Fast Track program allows more frequent interactions with the FDA and may lead to priority review and rolling review of a New Drug Application.
GLPG1972 is currently being evaluated in a Phase II study designed to enroll 850 patients in up to 15 countries (including 300 patients in the US). The primary endpoint is the change from baseline in cartilage thickness at week 52.
Our view – Targeting a large underserved market

Osteoarthritis is the most common joint disorder with an estimated global prevalence of 8.2%. Pharmacological treatments are mainly related to relief of symptoms and there is no disease-modifying OA drug yet approved by the regulatory agencies.
GLPG1972 acts on ADAMTS-5, an aggrecanase involved in the breakdown of aggrecan in joint cartilage. The compound has previously shown a positive safety and tolerability profile in healthy volunteers and demonstrated a strong, dose-dependent reduction of a biomarker of cartilage breakdown.
Investment conclusion

The Fast Track designation underpins the potential of GLPG1972 in this disease in high need of new treatment options. Given that at this stage we rely solely on biomarker data from a limited number of patients, we modeled conservative estimates and attributed a probability of success of 25% to the OA program, which results in a rNPV of EUR 184m (EUR 3.4/share). However, we believe GLPG1972 can become a valuable asset in this large underserved market once efficacy data in OA patients demonstrate the potential to effectively modify the course of the disease. Our investment case is today mainly driven by filgotinib, which will be the focus point in the coming quarters as the large FINCH-1 and 3 studies in rheumatoid arthritis read out. We reiterate our Buy recommendation.
avantiavanti
4
Cantor Fitzgerald 9 december

GILD CEO speculation debate may be over; appointing O'Day is positive, in our view

Bijlage:
avantiavanti
9
Kempen 13 december 2018

Galapagos
Everything you always wanted to know about MANTA, but were afraid to ask

Bijlage:
avantiavanti
12
Cantor Fitzgerald 19 december 2018

Galapagos N.V. ADR (GLPG - Overweight, Target: $130.00)
Could Filgotinib be a Best-in-Class JAK? Initiating at OW with $130 PT
Initiating Coverage
Bijlage:
Piddybull
3
Ik postte dit op beursig en Pate ondekte hierin ook deze link !!

cantor2.bluematrix.com/sellside/Email...

Avantiavanti , bij deze wederom erg bedankt voor het delen van deze info !

Bolknak_26F5
0
"There’s a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Galapagos NV (GLPG) and Gilead Sciences (GILD) with bullish sentiments".

www.smarteranalyst.com/brief/analysts...
avantiavanti
5
Alert UdatesPlus, 8 januari 2018

S1P modulator landscape becomes increasingly crowded…Phase 3 upadacitinib study in ulcerative colitis significantly delayed

Modulating T cell migration has become a popular approach to the treatment of IBD with strategies including the prevention of gut entry by integrin blockers (eg Entyvio) or the trapping of T cells within lymph nodes using an S1P modulator

Development of S1P modulators in IBD is supported in part by Celgene’s Ozanimod data. This molecule is currently in Phase 3 development for ulcerative colitis (TRUE NORTH) and Crohn’s disease. Arena is also developing an S1P modulator, Etrasimod (APD334) for ulcerative colitis. Positive topline Phase 2 data from the OASIS study were reported in Mar 2018

156 patients were randomized to receive placebo or etrasimod at 1mg or 2mg qd. At 2mg qd, etrasimod improved the primary endpoint, Mayo score improvement (3 component score on a 9pt scale: rectal bleeding, stool frequency and endoscopic score composite at 12wk)

Mayo score improved by 2.49 vs 1.50 units (2mg etrasimod vs placebo). Approx 30% patients were TNFi experienced, and interestingly 15% had previously received an integrin blocker

Key 12wk secondary endpoints included clinical remission (33% vs 8%) and endoscopic improvement (42% vs 18%). Arena has now announced data from the OLE of OASIS. 118 patients rolled into the OLE and 84 patients completed 34wk of treatment with 2mg etrasimod. Among these patients 39% achieved clinical remission, and 51% had endoscopic improvement at the end of the OLE study. This is similar to the response rate after 12wk treatment suggesting durable efficacy

Two earlier stage S1P modulators are in development for IBD. Chinese biotech, Connect Biopharma is developing CBP-307 and the company has now announced the receipt of $55M in funding which will be used to accelerate development of its drug candidates including CBP-307 for both Crohn’s and ulcerative colitis. In addition, Oppilan Pharma has announced that it has completed dosing of an initial 8 subjects in a Phase 1 study of OPL-002. Both of these candidates could enter Phase 2 development in 2019, contributing to an increasingly crowded segment

We close this alert with news on Abbvie’s JAK inhibitor, upadacitinib. Abbvie has been developing this candidate across multiple indications. The lead indication is rheumatoid arthritis with filing announced towards the end of 2018. The company has previously suggested that upadacitinib will be available for further indications in 2021 (atopic dermatitis and psoriatic arthritis) and 2022 (Crohn’s disease, ulcerative colitis and ankylosing spondylitis)

Abbvie opened a Phase 3 ulcerative colitis study in Oct 2018, randomizing 462 patients to a single dose of upadacitinib or placebo. [b]The primary endpoint of Mayo remission at 8wks was initially expected to read out around Jan 2021 however this has now been changed on CTG to July 2024. Moreover, a maintenance study has still not been posted

The timeline remains to be confirmed and if the study has been indeed been pushed back 3.5yrs reasons for this need to be understood. IBD studies have historically suffered delays due to competition for patients amongst other reasons however even by these standards today’s news is remarkable


Dr Jon Goldhill
Pharma information and reports LTD
UpdatesPlus/LeadDiscovery
avantiavanti
0

quote:

avantiavanti schreef op 9 jan 2019 om 07:30:




Domper voor Abbvie. Goed nieuws voor Galapagos die UC trial fully recruited heeft.

Alert UdatesPlus, 8 januari 2018

S1P modulator landscape becomes increasingly crowded…Phase 3 upadacitinib study in ulcerative colitis significantly delayed



Correctie, datum is natuurlijk 8 januari 2019
avantiavanti
9
Leerink Flash 25 januari 2019 (17.12h)
AbbVie filed the lower dose of upadacitinib for rheumatoid arthritis.
AbbVie announced that the lower 15mg upadacitinib (selective JAK1 inhibitor) dose has been submitted for regulatory approval for rheumatoid arthritis, due to an internal analysis of the data from the SELECT clinical program. Though no further details were disclosed, this choice is likely due the loss of JAK1 selectivity at higher doses noted in multiple assays. The higher 30mg dose did not confer a significant efficacy benefit relative to the 15mg, and has been discarded for this indication given the known safety liabilities and potential dose-dependent increases in these toxicities. The potential upadacitinib US approval date is unknown, but the guidance is in H2.


ABBVIE
NYSE: ABBV / MARKET PERFORM
($80.37, Mkt. Cap. $122B)

What Happened on the Call? 2019 Sales Guided Flat; $2bn ex-US Humira Headwind


Bottom Line: This morning AbbVie reported slightly soft Q4 2018 results with revenues of $8,305mm, <1% below consensus, and adjusted EPS of $1.90, under consensus by 2%. The results were driven by lower-than-expected Humira sales, a steep decline in AndroGel due to generic competition, and higher COGS, which could not be offset by strength from HCV sales, a lower tax rate, and share repurchases. EPS grew 27% driven in large part by 2018 tax reform and the recent share-repurchases. EBIT grew by 10% annually, which more realistically reflects the underlying business performance. AbbVie unveiled 2019 adjusted EPS guidance of $8.65-8.75, which brackets consensus. Revenue is expected to be flat, based on operational growth of 1% and an F/X headwind of 1%.


Key comments from the earnings call included…


AbbVie is definitively not contemplating a large M&A transaction.
Management was asked on the call about their appetite to execute a large, transformative M&A transaction, whether the takeover is friendly or unfriendly. Management offered a terse response that stated flat out that the company is not contemplating a large transaction that would involve a merger, and even added that they considered their prior Pharmacyclics transaction to a large acquisition (albeit a bolt-on).

Ex-US Humira biosimilars expected to erode $2bn in 2019, higher than previous estimate.
Full year 2018 ex-US Humira sales were $6,251mm, and AbbVie announced expectations for $2bn revenue erosion due to biosimilar competition in 2019. This translates into a ~30% decline for 2019, higher than the 26-27% decline AbbVie suggested was likely back on the Q3 call (which itself was materially higher than their prior expectations). Biosimilars are now competing in markets that encompass 75% of ex-US Humira, or 25% of global Humira revenues. The remaining 25% of ex-US Humira volume will face biosimilar competition in 2021. AbbVie has built into this forecast an expectation for continued price decline. Management stated that price is still evolving in Southern European countries and Germany and expects there to be a stabilization of erosion in 2020, and then another step down in 2021 as new markets lose exclusivity.

US Humira expected to grow only $1bn in 2019, below consensus expectations of +$1.4bn.
This guidance contemplates growth of 7%, down from 10% achieved in 2018. Management stated that this is not due to a change in volume trends, but is due to a lighter price contribution for the year. AbbVie executed one-time 6.2% price increases for some of its portfolio products in January 2019, which is less than the 9.7% increase taken in January 2018 for Humira.

AndroGel revenue will decline $400mm in 2019.
Exacerbating the decline of Humira sales, AbbVie also expect $400mm headwind for AndroGel in 2019 due to generic competition which started in Q4. This generic launch has already reduced sequential sales for the product by 44% in Q4 2018.

Despite headwinds, management expects double-digit earnings growth in 2019, which we believe is largely driven by share buybacks.
Management gave detailed guidance for product revenue and the P&L for 2019 (see the exhibit inside for guidance versus consensus and our estimates). AbbVie is guiding to essentially flat revenue for 2019, based on a 1% operational increase offset by a 1% F/X decline, but expects double-digit EPS growth in 2019. However, this is largely driven by the reduction in the Humira royalty rate and a reduction in share count delivered through 2018, which will continue into 2019 after the Board authorized a further $5bn buyback program in December 2018. Due to the Humira royalty decline, AbbVie is guiding to ~200bps of operating margin expansion in 2019 (up to 46.5%). On the call, management commented that future operating margin improvement to obtain the >50% goal will be driven by sales leverage, not expense reduction.

2020 targets seem unlikely to be achieved, which calls into question bullish 2025 targets.
Based on the trends AbbVie expects in 2019, it appears unlikely that the company will meet its previously announced 2020 targets of Humira sales of $21bn and an operating margin of >50%. Other prior guidance items that are questionable include Duodopa and Imbruvica.

AbbVie filed the lower dose of upadacitinib for rheumatoid arthritis.
AbbVie announced that the lower 15mg upadacitinib (selective JAK1 inhibitor) dose has been submitted for regulatory approval for rheumatoid arthritis, due to an internal analysis of the data from the SELECT clinical program. Though no further details were disclosed, this choice is likely due the loss of JAK1 selectivity at higher doses noted in multiple assays. The higher 30mg dose did not confer a significant efficacy benefit relative to the 15mg, and has been discarded for this indication given the known safety liabilities and potential dose-dependent increases in these toxicities. The potential upadacitinib US approval date is unknown, but the guidance is in H2.
AbbVie announced that an FDA Advisory Committee has not yet been announced, but it is common for new drugs in rheumatoid arthritis to go to an Advisory Committee and the company is planning for this possibility. AbbVie’s other new immunology asset, risankizumab for psoriasis, has a FDA PDUFA date of April 25.

Revenue missed consensus by <1%.
Global Humira sales declined 4% sequentially to $4,918mm, and were 1% below consensus of $4,978mm and 2% below our forecast of $5,005mm. US Imbruvica sales grew 3% sequentially to $839mm, which was 5% above consensus of $801mm and 1% above our forecast of $831mm. AbbVie’s ROW profit share for Imbruvica grew 4% q/q to $167mm and was 1% above consensus. AbbVie’s HCV revenue for the quarter from Viekira and Mavyret declined in the US but grew ex-US sequentially. US HCV revenue was $408mm, decreased 8% sequentially, and came in 1% above consensus estimates and 4% below our expectation. ROW HCV revenue was $454mm, increased 9% sequentially, and came in 12% above consensus estimates and 16% above our expectation.

EPS missed consensus by 2%.
Total non-GAAP expenses were $4,840mm, more than consensus (1%) and our estimate (6%), and were driven primarily by higher product and selling costs. AbbVie’s tax rate for Q4 was ~9%, which was 1 percentage point below expectations. Reported non-GAAP EPS was $1.90, which was 2% below consensus of $1.93 and 5% below our $2.01 estimate.

AbbVie unveiled 2019 guidance that brackets consensus.
AbbVie unveiled 2019 guidance for the first time today. AbbVie expects 2019 adjusted EPS to be in the range of $8.65-8.75, compared to consensus of $8.71 and our initial estimate of $8.54. See the exhibit inside for the detail of AbbVie’s product and P&L guidance.
Woman in Chains32
5
Thanks Avanti.

30 mg Upadacitinib dus niet eens gefiled door AbbVie...

Daarbij nog eens de mogelijkheid op een AdCom Meeting.

AbbVie earnings call transcript
Q4 cijfers 2018.

Vraag van Steve Scala Cowen:

Secondly, do you anticipate an FDA AdCom for upadacitinib?

Antwoord Michael Severino CSO van AbbVie:

Okay. So, this is Mike. I'll take number two. With respect to upa and the potential for an AdCom, I think it's important to keep in mind that we’re in very-early stages of a regulatory review. But, if you look at the practice of this review division, it's common for filings like this for new molecular entities in RA to go to an AdCom. So, it's certainly possible article. But, we’ll have a much better idea once we’re further along in the review process.



pe26: is Upadacitinib een new molecular entity..?

Er zijn al twee JAK's op de markt voor RA.
Zou het niet om de safety gaan, AbbVie..?

De 15mg safety Upadacitinib SELECT RA studies maar eens nader bekijken.
avantiavanti
16
Nomura Instinet 25/1/2019

FINCH 1 & 3 Readout Expectations
FINCH Data Key Milestone – Limited Downside,
Early MANTA Timeline Upside?


deel 1
Bijlage:
Woman in Chains32
2
@Avanti deel 2.

Nomura houdt de mogelijkheid open dat NDA Filgotinib wordt gedaan mid 2019!

Dat zou geweldig zijn.

"Potential NDA by mid 2019"

In een bullish scenario met PRV kan Filgotinib voor RA patiënten eind '19/ begin '20 op de USA-markt worden toegelaten.

Worden mooie weken als dit scenario zich gaat voltrekken.

Zou Gilead al veel meer weten (vooroverleg FDA).

Koersdoel $140 Nomura. Prima voor nieuwe ATH met FINCH 1/3 data op komst.
avantiavanti
0
Absoluut PE26! Als dit scenario doorgaat in combinatie met uitstekende Finches + UPA's drop of high dose en low dose nog een ?, moet toch vleugels gaan geven aan Filgotinib/Galapagos.
Xiaufight
0
De analisten zijn zeker opportunistisch over Manta. Terwijl Bart op de borrel er niet zoveel over kon zeggen. We weten dat ze nog aan het recruiteren zijn voor Manta maar dat de groep die ze nodig hebben lastig te vinden zijn. Ik ben dan ook benieuwd wanneer de laatste benodigde persoon wordt gerekruteerd.

Primary endpoint ligt op 13 weken tel daarbij op 10 weken gegevens verwerken (i.v.m. kleine studie). Deze weken bij elkaar opgeteld zitten we in begin juli.

Volgens mij is het alleen mogelijk om de filling mid-2019 te doen als de studie in deze week vol zitten. In februari zou er een update moeten komen op clinical trials dat de studie niet meer recruitmed is.

Hoe denken jullie hier over?
MtBaker
0
minder dan 3 per centrum, want meer dan 90 recruting dus gilead maximeert snelheid is mijn gedachte.
Fintech 13
0
Ik voeg het hier ook toe zodat het niet verloren gaat op het maanddraadje:

www.tijd.be/markten-live/nieuws/fonds...

Artikel in de tijd over Carmignac, waarbij ze de verwachtingen van aandelen voor EU voorspellen:

De Belgische biotechbedrijven Galapagos en Argenx krijgen een speciale vermelding. ‘Een belangrijke ontwikkeling in de Europese farmawereld is de opkomst van kleinere, innovatieve bedrijven. Dynamische spelers als Galapagos, Argenx en het Duitse MorphoSys zijn exact wat ‘big farma’ - met zijn ondermaatse investeringen in onderzoek en ontwikkeling - nodig heeft. Er liggen mogelijk licentieovereenkomsten of overnames in het verschiet.’
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Vertraagd 17-jan-20 17:35
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