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Galapagos maart 2016

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[verwijderd] 4 maart 2016 14:30

2015 Annual Results:
4 March 2016

welcome to the glpg webcast
Important points spoken here:

Operational Highlights (Onno):
- Filgotinib: potentially best-in-class in RA and Crohn’s
- Transformattional deal with gilead
- Cystic fibrosis program on track to triple combo therapy
- Succesfull listing on NASDAQ – fantastic IPO of importance because of extended R&D development
- Growth and progress in rest of pipeline
- Commercial rights in gilead deal will enbable to become an integrated bio company in coming years
- Deal with Gilead:
o Co-develop filgotinib in inflammatory diseases (20% of R&D costs for gala)
o Upfront of 725M (58 euro/ share
o Success-based milestones totalling 1.35B
o 50/50 profit split in co-promotion territories (big 5 european markets & benelux
o tiered royalties 20%+
o some important reasons to select GILEAD:
? chemistry between teams. Very good interaction between both teams
? higher trust level because of this
? impressive company with respect to building franchises (see HIV)
? Excellent partner to build uit the inflammation franchise
? Flag-Ship product in inflammation portfolio of GILEAD Their best eam on this!
- Clinical Pipeline:
o Rheumatoid arthritis
? JAK1 filgo: ph3 start H1 16
o Crohn’s
? Jak1 filgo wk 20 result april 2016
o Idiopathic pulmonary fibrosis (self program)
? Autotaxin 1690
• Ph2a start H1 16
o Cystic fibrosis Class 3
? 1837
• ph2 results H2 16
o Cystic fibrocis class 2
? 2222+ others
• ph1 results H1 16, other ph1 starts in H2 16
o osteoarthritis
? Novel MoA 1972
• Ph1 results in H1 16
o Inflammation (50/50 owned program)
? MOR 106
• Ph1 start H1 16

SAPHIRA on track: dose escalation of 4 weeks testing differnet dosages with follow up period afterwards. Trial divided:
SAPHIRA 1: G551D (more or equal than 12 pts)
SAPHIRA2: S1251N (more or equal than 6 patients

Including in 6 eu countries and australia
Included Kalydeco naive and treated (after 7d washout period)
Primary endpoints: safety and tolerability
Secondary endpoints: Sweat Chloride, FEV1, plasma levels

They are confident that we have topline data in second half of this year, ‘’ very exited’’

[verwijderd] 4 maart 2016 14:30

Financial results (less of importance if you ask me)
- 198,4 million at dec 14
- Cash position: 348,2 million euro’s at end of year 2015
- 259,4 million cash proceeds from ipo nasdaq
- post closing (jan 2016) : 1,015.0 billion

2015: Grands at other income: 21.0
milestone payments and other revenues: 7,7
free-for-service income: 5,4
recognition deferred revenues: 26,4

total of 60.6 million total for 2015, (2014 this was 90.0 million)

Operating expenses:
- Research expenses: 55,4 million
- Development expenses: 74,3 million
- S, G&A 20,3 million
Total of 150.0

S,G&A 2014 includes restructuring expense of 0.7 Million

(non-cash) Financial asset accounting

Financial asset / deferred income 16 dec 2015: 39.0 million
(non cash) 2015 p&L impact (share price increase) -30.6
(non-cash) 2016 p&l impact (share price decrease) 57.5m
total share premium: 39.0 (share premium recognized in p and l through amortization of deferred income). And 26.8 (share premium p&l in 2015/2016)

Share premium of 66m to be recognized in P&L over time

Net loss of 118 M.

GUIDANCE 2016
Expected cash burn of 100-120 million , exlcudes any cash income from filgotinib
- Lower spend on filgo, galapagos supports 20% of further development costs, compared to 100% of phase 2 costs in 2015
- Increased spend on cystic fibrosis and proprietary programs

[verwijderd] 4 maart 2016 14:30

2016 outlook (Onno)

- Ra & Crohn’s end of Ph2 meetings & Ph 3 designs (scheduled, relatively soon) possibly crohns earlier on market than RA!!
- Explore filgotinib combinations with gilead drug candidatest o boost efficacy. (SIC inhibitor? Or something like that to pronounce*) hope to see some innitiatives in this as well
- Contract expansion with AbbVie in cystic fibrosis alliance. ‘’ I can tell u to assure u this contract is good. Re-negotiating because of triple combo, so a number of the terms had to be re- discussed. Hope to announce an renewed alliance shortly
2451 Ph1 results in H2 16, 1837 Ph2 results in H2 16

(not sure, but i believe this is ‘SERVIER’: option to license this molecule for milestones. But they have the rights to deploy this in the US

higher boost to work on target discovery, and newer disease area’s.

Spreidstand 4 maart 2016 14:32

Onno: Moeten nog met FDA praten, willen 200mg gebruiken en zijn vol vertrouwen dat dit ook gaat gebeuren. Mag daar geen details over geven.

V: Hoe hoog zijn de milestones fase 3 RA en Crohns? A: Ook dat mogen we nog geen details over geven. 1.35 totaal. Short term geen info.

[verwijderd] 4 maart 2016 14:37

eindelijk de goede vraag, wat wordt er extern ingekocht

Spreidstand 4 maart 2016 14:39

Geld brandt niet in Onno's zak, ze zullen zeer weloverwogen keuzes maken hoe te besteden behalve aan pijplijn en ontwikkeling. Geeft verder geen antwoord wanneer en hoe de rest besteed wordt.

[verwijderd] 4 maart 2016 14:40

Q&A:
- Awaiting disuccions with FDA. Confident regarding the 200mg. But have to await with both EMA and FDA how the trial design and number of patients is going to be.
- Size of milestones for RA and Crohn’s: ‘can not disclose a number, but meaningful for them’
- Does outlook include milestones from abbvie cystic fibrosis partnership? And do patients have to be responded to that drug (inclusion/exclusion criteria)?
o Answer on outlook: cash burn includes all other except cash income from filgo. So also includes potential milestones or tax credits etc.
o Regarding SAPHIRA inclusion and exclusion criteria: will include patients that have an active response to current drug, wash out period. Also naive patients. (combination of both) regarding 1837 as potentiator for combination: possibilty but not yet definitve. We are developing 6 molecules in paralel to be able to make the best choise to move into phase 2. We plan to do as many combination analyses to make sure we have the right dosis regime. It is a short period of time to get the triple combo, but we are confident that we can make the right combination of the 3 based on previous studies. Not commited yet to any of the molecules, we keep all the options open.
- ‘Jan de Kerpel’ answers: ‘ competition with vertex, we don’t include patients in USA, because vertex heavily dominating there). What are we gonna do with the 1 billion:
o part of it will be used for further development of pipeline and infrastructure for market of filgo
always looking for opportunities, but we are very careful. (but try to expand pipeline). Not giving a lot a way, no dates on this one.

[verwijderd] 4 maart 2016 14:40

quote:
Spreidstand schreef op 4 maart 2016 14:30:
Ben ik de enige die de webcast aan het beluisteren is? Nu vragen van analisten..

Wat de ceo zegt neem ik aan als de reclameboodschap van een bakker, het brood is altijd vers. Vandaag. Morgen wellicht minder. i.e. kan altijd anders geïnterpreteerd worden. Kijk Straks en in het weekend wat de consensus van de analisten is en wat de US koers vanmiddag en de NL koers maandag doet. Dan pas bijkopen, of hoekje van de plank weer vrijmaken.

[verwijderd] 4 maart 2016 14:41

AB voor Spreidstand en Tradens!!!

Gilead Pipeline RA

GS-9876 (Syk inhibitor) Potential Indication: Rheumatoid Arthritis (Phase 1).
GS-5745 (MMP9 inhibitor) Phase 2 completed

Wordt toch de MMP9 in combi, die is ook verst gevorderd.

_Giulietta_ 4 maart 2016 14:45

Eindelijk voorzichtige koersreactie. :)

[verwijderd] 4 maart 2016 14:46

o of gilead comes up with more efficacy drug and just as safe, this could really blow away the existing programs in this area and blow away the competition in RA. Very very positive on combination products and they have high hopes on that.
o If MMP9 and filgo is used together, is that a risk in it self concerning money income etc. If efficacy is far superior, then combination product might overtake filgo as stand-alone product. But then anticipated that the royalties and incomes will be even higher because of the great efficacy

drulletje drie 4 maart 2016 14:46

quote:
_Giulietta_ schreef op 4 maart 2016 14:45:
Eindelijk voorzichtige koersreactie. :)

Jep we gaan beginnen ;)

Spreidstand 4 maart 2016 14:46

Might you consider acquiring a company with a sales force? That's an interesting thought. But if we find a commpany with an attractive product AND a sales force that is a possibility.

[verwijderd] 4 maart 2016 14:47

Wonderbaarlijk, en Giulietta zegt het mooi, voorzichtig. De CC doet echt het verschil maken vergeleken met de schriftelijke rapportjes.

[verwijderd] 4 maart 2016 14:48

- Have agreement on financial terms, but need to write this out. The extention is abou the fact that we are going with triple in stead of duo, and move all molecules into clinic, and this increases size and risk. And we need to be compensated with that on milestones. But there are no changes in marketing rights etc, just milestone changes.

*this sounded a dam lot like they are in a finishing state for this*

Opstapelen 4 maart 2016 14:49

meer dan prima call.

[verwijderd] 4 maart 2016 14:49

quote:
Spreidstand schreef op 4 maart 2016 14:46:
Might you consider acquiring a company with a sales force? That's an interesting thought. But if we find a commpany with an attractive product AND a sales force that is a possibility.

Onno is heel vastberaden en weet exact wat hij wilt. Het beste voor Galapagos. Dat kun je aflezen uit zijn reacties en manier van enthousiast spreken!

[verwijderd] 4 maart 2016 14:50

quote:
Tradens schreef op 4 maart 2016 14:48:
- Have agreement on financial terms, but need to write this out. The extention is abou the fact that we are going with triple in stead of duo, and move all molecules into clinic, and this increases size and risk. And we need to be compensated with that on milestones. But there are no changes in marketing rights etc, just milestone changes.

*this sounded a dam lot like they are in a finishing state for this*

Ja he!

[verwijderd] 4 maart 2016 14:50

korte samenvatitng van what to come in 2016 wat we nog niet wisten: geen nieuwe voorwaarden voor CF betreft marketing, wel nieuwe milestones hierbij inbegrepen (wellicht iets teleurstellend?). en mogelijk combinatie met GILEAD hun eigen medicijn, dit zal echter 2-3 jaar achter filgotinib aankomen. verder allemaal al vrij veel hetzelfde

[verwijderd] 4 maart 2016 14:50

quote:
Baas93 schreef op 4 maart 2016 14:47:
Wonderbaarlijk, en Giulietta zegt het mooi, voorzichtig. De CC doet echt het verschil maken vergeleken met de schriftelijke rapportjes.

moet je je proberen voor te stellen wat er zou kunnen gebeuren als ze iets zouden melden dat nieuws is in plaats van 'no comment' in diverse bewoordingen.....

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