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Wall Street Trader
2
Jefferies

GILEAD SCIENCES

Continued Good News on Improving Story (Filgotinib)

July 1, 2019

Key Takeaway

GILD announced incrementally positive news that supports our view that things are getting relatively better and the story is turning around. Based on a pre-NDA meeting
and a discussion with the FDA around the recent positive Phase III data and the ongoing
Phase II male toxicity study (MANTA), GILD announced that the FDA agreed there is a
path forward to file an NDA for filgotinib in 2019.


This is an incremental positive surprise as the Street has been uncertain about whether
a filing in 2019 was even possible.
When filgotinib's pivotal program started, the agency
said GILD was required to complete the male toxicity study, which had been enrolling
very slowly and therefore suggested an NDA filing later in 2020. Today's announcement
makes a filing more likely to occur later this year, so GILD is not that far behind ABBV
which filed around 6 months ago. An outstanding question is whether GILD has a priority
review voucher handy and thus can keep the timing tight, since ABBV used a priority
voucher for upadacitinib to expedite the regulatory decision to Q3:19.

To be balanced and fair, we acknowledge from GILD's press release that there is a
"path forward" to filing in 2019.
It appears to us that the conversation would be likely
conducting an interim pooled analysis in Q3 so that they could file upon that event. Other
outstanding questions are of course if the male toxicity study turned out to be positive
or negative and whether that would impact GILD's ability to file. If positive, we would
certainly argue everything would be very good and GILD would be very competitive if not
best-in-class compared to ABBV. If data was negative and the drug did cause a reduction
in sperm count, this scenario wouldn't appear to block GILD's ability to file. Rather, it
would be an issue in the label, which isn't too commercially relevant in our opinion given
that these indications comprise of mostly females.


Lama Daila
2
quote:

Lama Daila schreef op 30 juni 2019 16:19:


www.researchpool.com/provider/bryan-g...

Bryan Garnier: GALAPAGOS | Buy | FV EUR140 | (MANTA) With or Without You

Gilead is heading into a pre-BLA meeting to discuss data from the FINCHes trials and the filing timelines for filgotinib. The outcome of this meeting should be communicated in the coming weeks.



De link naar de volledige nota stond in de recente nota die AvantiAvanti hier plaatste:
medias.bryangarnier.com/equity/pdf/FO...

harvester
0
Na de nu bekende updates gelezen te hebben, vind ik de updates wel positief, maar vindt de aanpassing van de koersdoelen wat beperkt.

Ik had wel wat meer verwacht.
Dat GS houden zegt en het koersdoel niet opkrikt naar de huidige koers vind ik wat tegenstrijdig "to put it mildly", zeker nadat Galapagos ook op hun conferentie present is geweest.

Wellicht willen veel banken de 2e kwartaal rapportages van Gilead afwachten en daarbij mogelijk nieuws over het al of niet inzetten van de priority review.

Als ik mij niet vergis kunnen wij nog updates verwachten van een 3 tal banken waaronder Berenberg. Wellicht dat die wel wat aan hun koersdoel doet.



avantiavanti
14
Citi 9 juli 2019

Verhoogt pt van 115 euro naar 140 euro

Raising Price Target to €140 on Likely Filgotinib US Filing in 2019
Bijlage:
avantiavanti
4
Kempen 15 juli 2019

This is how you do it.

Gilead and Galapagos entered a collaboration granting Gilead options
for ex-EU rights for anything coming from Galapagos' pipeline for the
next 10 years in exchange for $3.95b upfront, $1.1b equity investment
plus multibillion future milestones. In all, the deal seems like a total
win-win for both parties where Gilead finally gets the late-stage
pipeline and exciting R&D engine, and Galapagos gains a strong and
committed commercial partner, who will help build Galapagos' own
infrastructure, and desired independence from takeover attempts
and financial markets, while further expanding the R&D to discover
novel targets. Just reflecting the upfront, equity investments and the
nearterm milestones and royalties on the proprietary pipeline in our
model, without a potential commercial advantage from having Gilead
as a partner, our PT goes to €180 ($160 for ADR) from €135 ($120).
Galapagos continues to feature on our favorites list.

Bijlage:
avantiavanti
2
Extract uit Morgan Stanley update 15 juli 2019

Long-term Collaboration Provides Opportunity for Both Gilead and Galapagos

Gilead and Galapagos announced a $5.1B, 10 year strategic partnership for exEU rights to Galapagos' pipeline. The deal provides Gilead with a proven target discovery engine and expanded late-stage pipeline. It enables Galapagos to grow its discovery engine and build an integrated biopharma co.

Gilead and Galapagos announce a 10 year strategic pipeline transaction: Gilead will pay $3.95B upfront and buy $1.1B of Galapagos stock at a 20% premium to the 30 day weighted average price ( €140.59/share) for rights to Galapagos' pipeline outside of Europe for 10 years. The deal excludes MOR106. Specifically, Gilead has the right to opt-in to any program post-PhII for $150M upfront and 20-24% in royalties. Current clinical programs GLPG1690 and GLPG1972 are also included with the former carrying a $325M US approval milestone and the latter a $250M opt-in after PhIIb and up to $750M in milestones. All programs carry 50/50 cost-sharing post opt-in. The filgotinib deal has been restructured to include 50/50 global cost sharing and a 50/50 profit split with Galapagos in the EU5 (expanded from just Benelux region). Importantly, Gilead's equity investment in Galapagos will bring Gilead's ownership to ~22%. Gilead will receive two warrants to increase its ownership to 29.9%, subject to a shareholder vote. The first warrant, with a 1 year term, can increase Gilead's stake to 25% with a €140.59 strike price. The second warrant, with a 10 year term, can increase Gilead's stake to 29.9% and carries a 20% premium to Galapagos' stock price when exercised. The deal also includes a 10 year standstill.

Impact to Gilead (EW, PT $83): The practical impact of this transaction is that it grows Gilead's mid-to-late stage pipeline in inflammatory diseases overnight, providing key potential catalysts in the early-to-mid-2020s. Importantly, it also significantly expands Gilead's discovery capabilities and delivers a potential steady stream of pipeline opportunities, an area that has been lacking at Gilead. Importantly, in our conversations with mgt. we believe the rationale for this deal was a portfolio approach to expanding the long-term pipeline at Gilead and does not rest on a single asset. However, just as important, mgt. indicated it will continue to look toward opportunities to rebuild Gilead's pipeline suggesting that this is not the only deal it will pursue. Overall we see the strategic rationale for the deal as solid and look forward to mgt.'s full strategic plan in the fall.

Impact to Galapagos: We see three key impacts from this deal. First, Galapagos now has the capital to prosecute its broad pipeline, but maintains the independence of early clinical decisions so that it can continue to drive key programs into the clinic and through proof-of-concept quickly. Second, mgt. can now expand its target discovery engine from ~500 to ~1,000 scientists to drive higher through-put of novel targets which in turn can lead to an expanded clinical pipeline. Finally, the deal also accelerates mgt.'s goal of delivering an integrated biopharma organization which will have a strong European commercial presence. Together this expands Galapagos' clinical and commercial potential.

Morgan Stanley is currently acting as a financial advisor to Galapagos N.V. (“Galapagos") in relation to its agreement to enter into a 10-year global collaboration with Gilead Sciences, Inc. that covers Galapagos’ current and future portfolio (the “Collaboration”), as announced on July 14, 2019.

The proposed transaction is subject to required regulatory approvals and other customary closing conditions and certain elements of the Collaboration are subject to the approval of Galapagos’ shareholders. Galapagos has agreed to pay fees to Morgan Stanley for its services that are contingent upon the consummation of the proposed transaction.
C200
0
quote:

avantiavanti schreef op 15 juli 2019 10:45:


Kempen 15 juli 2019

This is how you do it.

Gilead and Galapagos entered a collaboration granting Gilead options
for ex-EU rights for anything coming from Galapagos' pipeline for the
next 10 years in exchange for $3.95b upfront, $1.1b equity investment
plus multibillion future milestones. In all, the deal seems like a total
win-win for both parties where Gilead finally gets the late-stage
pipeline and exciting R&D engine, and Galapagos gains a strong and
committed commercial partner, who will help build Galapagos' own
infrastructure, and desired independence from takeover attempts
and financial markets, while further expanding the R&D to discover
novel targets. Just reflecting the upfront, equity investments and the
nearterm milestones and royalties on the proprietary pipeline in our
model, without a potential commercial advantage from having Gilead
as a partner, our PT goes to €180 ($160 for ADR) from €135 ($120).
Galapagos continues to feature on our favorites list.




Vreemd, PT voor ADR is lager. Je zou denken dat het andersom moet zijn, toch?
$180 en €160.
MtBaker
0
quote:

C200 schreef op 15 juli 2019 10:51:


[...]

Vreemd, PT voor ADR is lager. Je zou denken dat het andersom moet zijn, toch?
$180 en €160.

tijd voor een bezoekje aan de brillennwinkel, maar het kijkt inderdaad te kloppen.
Sir Piet
0
quote:

C200 schreef op 15 juli 2019 10:51:


[...]

Vreemd, PT voor ADR is lager. Je zou denken dat het andersom moet zijn, toch?
$180 en €160.


Ze houden er al rekening mee dat de euro flink in waarde daalt denk ik zo..............
Pokerface
0
KBC verhoging:

Beursblik: KBC Securities verhoogt koersdoel Galapagos
Redactie De Aandeelhouder - maandag, 15 juli 2019
Koopadvies behouden.

(ABM FN) KBC Securities heeft maandag het koersdoel voor Galapagos maandag verhoogd van 128,00 naar 145,00 euro met een ongewijzigd koopadvies.





Volgens analist Lenny Van Steenhuyse heeft Galapagos een "royale deal" met Gilead getekend. Deze overeenkomst geeft volgens de analist Galapagos nog eens tien jaar de tijd om met zijn Amerikaanse partner programma’s na te streven terwijl het de mogelijkheid biedt om commerciële expertise te ontwikkelen in Europa.

Onder de uitgebreide samenwerking ontvangt Galapagos een vooruitbetaling van 3,95 miljard dollar en investeert Gilead voor 1,1 miljard dollar in aandelen. Galapagos gaat deze middelen inzetten om haar R&D-activiteiten uit te breiden en te versnellen.

Naar aanleiding van het nieuws over de investering van Gilead in Galapagos en een aanzienlijke kasinstroom tegen eind 2019, KBC Securities mikt op een instroom van 0,5 miljard euro, besloot de analist tot de koersdoelverhoging.

Het aandeel Galapagos koerste maandag kort na opening 17,3 procent hoger op 150,55 euro.
Wall Street Trader
0
Analyst Price Targets (Updated)


RBC Sector Perform Price Target € 132

Citigroup Smith Barney Price Target € 140

JP Morgan Price Target € 165

Kempen Price Target € 180

KBC Price Target € 145

Jefferies & Co. Price Target € 130

Bryan Garnier & Co Price Target € 180



Pl4
0
quote:

Wall Street Trader schreef op 15 juli 2019 12:02:


Analyst Price Targets (Updated)


RBC Sector Perform Price Target € 132

Citigroup Smith Barney Price Target € 140

JP Morgan Price Target € 165

Kempen Price Target € 180

KBC Price Target € 145

Jefferies & Co. Price Target € 130

Bryan Garnier & Co Price Target € 180






Most of them are wrong.. but they'll catch up later.
voda
0
Video: heel positief nieuws voor Galapagos

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Galapagos
149,25 21,10 16,47 % Euronext Amsterdam

(ABM FN-Dow Jones) Galapagos heeft een heel goede deal met Gilead gesloten. Dit zei analist Corne van Zeijl van Actiam voor de camera van ABM Financial News.

Er zit volgens Van Zeijl echter ook "een negatieve kant" aan het verhaal voor beleggers. De overnamekansen voor Galapagos zijn "nihil" geworden.

Al met al meent de analist echter dat het positief nieuws is voor Galapagos.

www.youtube.com/watch?v=4XcWz5I_jqg

Door: ABM Financial News.
info@abmfn.nl
Redactie: +31(0)20 26 28 999

© Copyright ABM Financial News B.V. All rights reserved.
avantiavanti
4
SVB Leerink 15 juli 2019

Galapagos, Long Recognized as Technical Powerhouse, Rewarded
with Independence
Bijlage:
Wall Street Trader
0
quote:

Pl4 schreef op 15 juli 2019 12:17:


[...]

Most of them are wrong.. but they'll catch up later.


Filgotinib’s deal term slightly changed.

Fair value would be about € 180

But a lot of models / price targets are currently under review.

avantiavanti
3
H.C.Wainwright&Co 15 juli 2019

Gilead Opts for Decentralized R&D Model With
a $5.1B Collaboration; Target to $205 From $150
Bijlage:
avantiavanti
3
Extract Nomura Instinet 15 juli 2019

First Look: Galapagos NV (GLPG US, Buy) - GILD Deal: Best Outcome Short of M and A

Christopher Marai, Ph.D. - ILLC

On Sunday, July 14th, GLPG and GILD published a press release and hosted a conference call on a revised R&D collaboration with highly favorable terms for GLPG (PR here, presentation here, collaboration overview here). Briefly, GILD will pay GLPG $3.95bn upfront, and make a $1.1bn investment in the company (consisting of a subscription for new GLPG shares at 140.59 EUR per share, or ~$158.45). This investment increases GILD’s stake to 22% of issued and outstanding shares—however, the collaboration contains a 10-year standstill restricting GILD from trying to increase its stake beyond 29.9%. Overall, the deal is structured to give GILD access to GLPG’s pipeline and to yield some commercial control over filgotinib to GLPG in Europe. The deal also prevents GILD from taking over GLPG for the next 10 years, making this deal the best outcome for GLPG short of full acquisition, in our view. NOTE: our current target price is below the last closing as we evaluate our estimates; our rating remains Buy.

Previous GILD/GLPG Deal: Filgotinib-Centric with GILD Taking Commercial Lead and 80:20 Cost Split. In 2016, GILD closed a licensing and collaboration agreement with GLPG for filgotinib. GILD has an exclusive, WW, royalty bearing license for filgotinib and was primarily responsible for development and regulatory approval. GILD was responsible for 80% of costs incurred (and GLPG responsible for 20%). GILD made an upfront license fee payment of $300mn and a $425mn equity investment in GLPG (at the time, representing 14.75% of GLPG’s outstanding share capital). GLPG was eligible to receive regulatory milestone-based payments of up to $755mn, sales-based milestone payments of up to $600mn, and tiered royalties on global net sales from 20-30% (with exception of certain co-promotion territories where profits would be split, which include the UK, Germany, France, Italy, Spain, the Netherlands, Belgium, and Luxembourg).

Current Revised GILD/GLPG Deal: Greater GLPG Involvement in Commercializing Filgotinib in Europe, and 50-50 Cost Split; GILD Now Has Rights to GLPG1690 (IPF, Ph3) and GLPG1972 (OA, Ph2b). The new collaboration agreement retains GILDs WW rights and co-development with GLPG in UK, Germany, France, Italy, and Spain. However, GLPG now has exclusive rights in the Netherlands, Belgium, and Luxembourg. In exchange for this expanded commercial role, GLPG will now have to split the costs 50-50 with GILD instead of 20-80. Importantly, GILD now has rights to GLPG pipeline, including outright rights to GLPG1690 for idiopathic pulmonary fibrosis (IPF) and an option for rights on GLPG1972 for osteoarthritis (OA). If ‘1690 is approved, GILD will pay GLPG $325mn; if GILD exercises its option for ‘1972, GILD will pay $250mn after completion of the Ph2b in OA (and an additional $200mn if certain secondary endpoints are met). GLPG would be eligible for $550mn in regulatory and commercial milestones if GILD opts in on ‘1972.

Conference Call Focus Was Around GLPG’s R&D Platform and Downplayed Recent Filgotinib Results as Driving Factor. We noted the conference call’s focus was on GILD’s interest in GLPG’s target and drug discovery platform. GILD emphasized their access to GLPG’s IP and programs in inflammation and fibrosis. GILD’s O’Day would not break down how GILD’s investment varied by assets and said that he believe their investment is holistic toward GLPG’s pipeline. In the Q&A, management from both companies downplayed the recent news on filgotinib US filing as an impetus for the deal—O’Day noted long-standing interest on expanding this collaboration (even prior to O’Day joining GILD), and the framework for the deal appears to have been largely set even prior to the recent filgotinib updates.

‘1690 and IPF: High Unmet Need Market with 200K Patients in US and EU; 2017 Sales of Poorly Tolerated Nintedanib and Pirfenidone Was $1.9bn. GILD now has rights to ‘1690, an autotaxin inhibitor to block the bioactive signaling molecule LPA. It is a first-in-class inhibitor of autotaxin. The Ph2b data from FLORA was published in the “The Lancet, Respiratory Medicine). No important safety or tolerability issues were identified, and FVC was stabilized at week 12. With respect to the current collaboration, GILD does not have access to any unblinded data from the ongoing Ph3 studies ISABELLA 1 and 2 but did have unblinded access to safety data. We believe this may be important, as we had previously been concerned about theoretical toxicity from blocking LPA in the CNS. GILD’s interest after seeing unblinded safety data bodes well for the drug, in our view. Recall, this is a high unmet disease population, where 50% of patients die within 2-5 years post-diagnosis. The SOC include pirfenidone and nintedanib, which only slow down decline in lung function and are poorly tolerated (25% discontinuation rate due to AEs). 2016 pricing for pirfenidone and nintedanib was ~$95K/year/patient.
voda
0
Beursblik: InsingerGilissen verhoogt koersdoel Galapagos

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Galapagos
150,60 22,45 17,52 % Euronext Amsterdam

(ABM FN-Dow Jones) InsingerGilissen heeft het koersdoel van Galapagos verhoogd van 150,00 naar 200,00 euro met een ongewijzigd Aanbevolen advies. Dit bleek maandag uit een analistenrapport.

Volgens analist Jos Versteeg heeft Galapagos een prachtige deal gesloten met Gilead Sciences waarbij het Belgisch-Nederlandse biotechbedrijf zijn zelfstandigheid behoudt.

Versteeg wees voor de camera van ABM Financial News op twee belangrijke doelstellingen die Galapagos CEO Onno van de Stolpe heeft: het bedrijf zelfstandig houden en een onafhankelijke Europese farmaceut worden.

Dat eerste is door de deal met Gilead gelukt gezien de wapenstilstand van 10 jaar. Volgens Versteeg hoeft Galapagos niet bang te zijn dat er een bod zal komen want Gilead kan zijn belang uitbreiden tot net onder 30 procent en "daarmee is het volstrekt zinloos voor een andere farmaceut om een bod te doen".

Het tweede doel van de Galapagos topman, dat wil zeggen een onafhankelijke farmaceut worden, daar heeft hij "ook een grote stap mee gemaakt", vindt Versteeg, omdat Galapagos in de toekomst alle medicijnen in Europa zelf mag ontwikkelen en deels ook vermarkten.

Het aandeel Galapagos noteerde maandagmiddag bijna 17 procent hoger op 149,75 euro.

Door: ABM Financial News.
info@abmfn.nl
Redactie: +31(0)20 26 28 999

© Copyright ABM Financial News B.V. All rights reserved.
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