Frans Verstraete
Transcript of Frans Verstraete
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 1/75
(8SROLF\RQXQGHVLUDEOHVXEVWDQFHVLQIHHG
)UDQV9HUVWUDHWH
(XURSHDQ&RPPLVVLRQ
'*+HDOWKDQG&RQVXPHU
3URWHFWLRQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 2/75
287/,1(35(6(17$7,21
2YHUDOOUHJXODWRU\IUDPHZRUNIRUIHHGDQGIRRGVDIHW\OHJLVODWLRQ
5HJXODWRU\IUDPHZRUNIRUFRQWDPLQDQWVLQIRRG 5HJXODWRU\IUDPHZRUNIRUXQGHVLUDEOHVXEVWDQFHVLQ
IHHG 'HFLVLRQPDNLQJSURFHVVLQWKH(8 ,QWHUSUHWDWLRQRIDQDO\WLFDOUHVXOWVIRURIILFLDOFRQWURO 6SHFLILFSURYLVLRQVRQP\FRWR[LQVLQLQIHHGDQGIRRG
6SHFLILFSURYLVLRQVRQRWKHUXQGHVLUDEOHVXEVWDQFHVLQIHHG )XWXUHGLVFXVVLRQVXQGHVLUDEOHVXEVWDQFHVLQIHHG &RQFOXVLRQV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 3/75
(8)5$0(:25.)(('$1')22'6$)(7<
5HJXODWLRQ(&RIWKH(XURSHDQ5HJXODWLRQ(&RIWKH(XURSHDQ
3DUOLDPHQWDQGRIWKH&RXQFLORI-DQXDU\3DUOLDPHQWDQGRIWKH&RXQFLORI-DQXDU\
OD\LQJGRZQWKHJHQHUDOSULQFLSOHVDQGOD\LQJGRZQWKHJHQHUDOSULQFLSOHVDQG
UHTXLUHPHQWVRIIRRGODZHVWDEOLVKLQJWKHUHTXLUHPHQWVRIIRRGODZHVWDEOLVKLQJWKH
(XURSHDQ)RRG6DIHW\$XWKRULW\DQGOD\LQJ(XURSHDQ)RRG6DIHW\$XWKRULW\DQGOD\LQJGRZQSURFHGXUHVLQPDWWHUVRIIRRGVDIHW\GRZQSURFHGXUHVLQPDWWHUVRIIRRGVDIHW\
³7KH*HQHUDO)RRG/DZ*)/´
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 4/75
*(1(5$/)22'/$:6FRSHDQGREMHFWLYHV
$SSOLHVWRDOOVWDJHVRIWKHSURGXFWLRQSURFHVVLQJDQGGLVWULEXWLRQRIIRRGDQGDOVRRIIHHGSURGXFHGIRURU IHGWRIRRGSURGXFLQJDQLPDOV
³IDUPWRIRUN´DSSURDFK 3URYLGHVWKDWIRRGODZVKDOOSXUVXHRQHRUPRUHJHQHUDOREMHFWLYHVRIDKLJKOHYHORISURWHFWLRQRI KXPDQKHDOWKDQGWKHSURWHFWLRQRIFRQVXPHUV¶
LQWHUHVWVDQGRIZKHUHDSSURSULDWHWKHSURWHFWLRQRI DQLPDOKHDOWKDQGZHOIDUHSODQWKHDOWKDQGWKHHQYLURQPHQW
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 5/75
*(1(5$/)22'/$:2EMHFWLYHV
3URYLGHVWKDWIRRGODZVKDOODLPWRDFKLHYHWKHIUHHPRYHPHQWLQWKH&RPPXQLW\RIIHHGDQGIRRGPDQXIDFWXUHGRUPDUNHWHGDFFRUGLQJWRWKHJHQHUDO
SULQFLSOHVDQGUHTXLUHPHQWVRIIRRGODZ 3URYLGHVWKDWZKHQLQWHUQDWLRQDOVWDQGDUGVH[LVWRU WKHLUFRPSOHWLRQLVLPPLQHQWWKH\VKDOOEHWDNHQLQWRFRQVLGHUDWLRQLQWKHGHYHORSPHQWRIIRRGODZH[FHSW
ZKHUHVXFKVWDQGDUGVZRXOGEHDQLQHIIHFWLYHRU LQDSSURSULDWHPHDQVIRUWKHIXOILOPHQWRIWKHOHJLWLPDWHREMHFWLYHVRIIRRGODZ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 6/75
*(1(5$/)22'/$:5LVNDQDO\VLV
z ,QRUGHUWRDFKLHYHWKHJHQHUDOREMHFWLYHRIDKLJKOHYHORISURWHFWLRQRIKXPDQKHDOWK(8IHHGIRRGOHJLVODWLRQVKDOOEHEDVHGRQULVNDQDO\VLVSURFHVVFRQVLVWLQJRIWKUHHLQWHUFRQQHFWHGFRPSRQHQWVULVNDVVHVVPHQWULVNPDQDJHPHQWULVNFRPPXQLFDWLRQH[FHSWZKHUHWKLVLVQRWDSSURSULDWHWRWKHFLUFXPVWDQFHVRUWKHQDWXUHRIWKHPHDVXUHHJODEHOOLQJ
z 5LVNDVVHVVPHQWVKDOOEHEDVHGRQWKHDYDLODEOHVFLHQWLILFHYLGHQFHDQGXQGHUWDNHQLQDQLQGHSHQGHQWREMHFWLYHDQGWUDQVSDUHQWPDQQHU
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 7/75
*(1(5$/)22'/$:5LVNPDQDJHPHQW
z 5LVNPDQDJHPHQWVKDOOWDNHLQWRDFFRXQW
WKHUHVXOWVRIULVNDVVHVVPHQWRWKHU
IDFWRUVOHJLWLPDWHWRWKHPDWWHU XQGHU FRQVLGHUDWLRQDQGWKHSUHFDXWLRQDU\SULQFLSOH
ZKHUHDSSURSULDWH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 8/75
&RQWDPLQDQWVIRRG&RXQFLO5HJXODWLRQ
z 5HJXODWRU\IUDPHZRUNIRUFRQWDPLQDQWVLQ
IRRG
&RXQFLO5HJXODWLRQ((&1RI)HEUXDU\OD\LQJGRZQ&RPPXQLW\
SURFHGXUHVIRUFRQWDPLQDQWVLQIRRG
WKLV5HJXODWLRQGRHVQRWDSSO\WRFRQWDPLQDQWVZKLFK
DUHWKHVXEMHFWRIPRUHVSHFLILF&RPPXQLW\UXOHVVXFK
DVSHVWLFLGHUHVLGXHVYHWHULQDU\GUXJUHVLGXHV«
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 9/75
5HJXODWLRQ3URYLVLRQV
z *HQHUDOSURYLVLRQ ± IRRGFRQWDLQLQJDFRQWDPLQDQWLQDQDPRXQW
ZKLFKLVXQDFFHSWDEOHIURPWKHSXEOLFKHDOWK
YLHZSRLQWDQGLQSDUWLFXODUDWDWR[LFRORJLFDOOHYHOVKDOOQRWEHSODFHGRQWKHPDUNHW
z *RRGSUDFWLFH
± FRQWDPLQDQWOHYHOVVKDOOEHNHSWDVORZDVFDQUHDVRQDEO\EHDFKLHYHGIROORZLQJJRRGSUDFWLFHVDWDOOVWDJHV$/$5$
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 10/75
5HJXODWLRQ3URYLVLRQV
z :KHQQHFHVVDU\IRUSURWHFWLQJSXEOLFKHDOWKPD[LPXPOHYHOVVKDOOHVWDEOLVKHGIRUVSHFLILFFRQWDPLQDQWV!3URFHGXUHIRUVHWWLQJ
PD[LPXPOHYHOV7KLVFDQDOVRLQFOXGHDUHIHUHQFHWRWKHVDPSOLQJDQGDQDO\VLVPHWKRGVWREHXVHG
z 2EOLJDWRU\FRQVXOWDWLRQRIWKH(XURSHDQ)RRG6DIHW\$XWKRULW\()6$3DQHORQFRQWDPLQDQWVLQWKHIRRGFKDLQEHIRUHSURYLVLRQVKDYLQJ
HIIHFWXSRQSXEOLFKHDOWKVKDOOEHDGRSWHG
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 11/75
5HJXODWLRQ3URYLVLRQV
z VDIHJXDUGFODXVHDVFRQVHTXHQFHRIQHZLQIRUPDWLRQ
RUUHDVVHVVPHQWRIH[LVWLQJLQIRUPDWLRQ!VXVSLFLRQRI
FRQVWLWXWLQJDKHDOWKULVNDOWKRXJKFRPSO\LQJ(8
OHJLVODWLRQz LQWHUQDOPDUNHWQRUHVWULFWLRQRQSODFLQJRQWKHPDUNHW
IRUIRRGVFRPSO\LQJZLWK(8OHJLVODWLRQIRUUHDVRQV
UHODWLQJWRWKHLUFRQWDPLQDQWFRQWHQWz FRPSHWHQW6WDQGLQJ&RPPLWWHH6WDQGLQJ&RPPLWWHH
RQWKH)RRG&KDLQDQG$QLPDO+HDOWK
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 12/75
6HWWLQJUHJXODWRU\OLPLWVIRUFRQWDPLQDQWV±IRRG
z 6FLHQWLILFULVNDVVHVVPHQW ± DVVHVVPHQWRIWKHULVNVUHODWHGWRWKHSUHVHQFHRID
FRQWDPLQDQWLQIRRGVWXIIVIRUKXPDQKHDOWKHVWDEOLVKPHQWRIDWROHUDEOHLQWDNHKHDOWKEDVHGJXLGDQFHYDOXH
± H[SRVXUHDVVHVVPHQWKXPDQH[SRVXUHDYHUDJHDQGSHUFHQWLOH3DUWLFXODUDWWHQWLRQWRYXOQHUDEOHJURXSVRI SRSXODWLRQKLJKOHYHOFRQVXPHUV
± 5LVNFKDUDFWHULVDWLRQKXPDQH[SRVXUHDVVHVVHGLQUHODWLRQWRWKHKHDOWKEDVHGJXLGDQFHYDOXH
!LVWKHEDVLVIRUWKHPHDVXUHVWREHWDNHQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 13/75
6HWWLQJUHJXODWRU\OLPLWVIRUFRQWDPLQDQWV±IRRG
z 'HWHUPLQDWLRQRIIRRGVIRRGJURXSVVLJQLILFDQWO\FRQWULEXWLQJWRWKHH[SRVXUH
z 2FFXUUHQFHGDWDRIWKHFRQWDPLQDQWLQWKHYDULRXVIRRGIRRGJURXSV
z 6HWWLQJDPD[LPXPOHYHOIROORZLQJWKH$/$5$SULQFLSOH$V/RZ$V5HDVRQDEO\$FKLHYDEOH
7KHGHJUHHRIVHYHULW\RIWKHDSSOLFDWLRQRIWKLVSULQFLSOHGHSHQGVRQWKHUHODWLRQH[SRVXUHWROHUDEOHLQWDNHULVNFKDUDFWHULVDWLRQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 14/75
&RQWDPLQDQWVIHHG'LUHFWLYH(&
z 5HJXODWRU\IUDPHZRUNIRU
FRQWDPLQDQWVXQGHVLUDEOHVXEVWDQFHVLQIHHG
± 'LUHFWLYH(&RIWKH(XURSHDQ3DUOLDPHQWDQGRIWKH&RXQFLORI0D\RQXQGHVLUDEOH
VXEVWDQFHVLQDQLPDOIHHG
WKLV'LUHFWLYHGRHVQRWDSSO\WRYHWHULQDU\PDWWHUVUHODWLQJWRSXEOLFDQGDQLPDOKHDOWKUHJXODWHGE\RWKHU
&RPPXQLW\UXOHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 15/75
&RQWDPLQDQWVIHHG'LUHFWLYH(&
z *HQHUDOSURYLVLRQ
± 3URGXFWVLQWHQGHGIRUDQLPDOIHHGPD\HQWHUIRU XVHLQWRWKH&RPPXQLW\EHPDUNHWHGDQGXVHGLQWKH&RPPXQLW\RQO\LIWKH\DUHVRXQGJHQXLQHDQGRIPHUFKDQWDEOHTXDOLW\DQGWKHUHIRUHGRQRWUHSUHVHQWDQ\GDQJHUWRKXPDQKHDOWKDQLPDOKHDOWKRUWRWKHHQYLURQPHQWRUGRDGYHUVHO\DIIHFWOLYHVWRFNSURGXFWLRQ
± 0D[LPXPOHYHOVDQGDFWLRQOHYHOVFDQEHVHWIRU FRQWDPLQDQWVLQDOOSURGXFWVLQWHQGHGIRUDQLPDOIHHG
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 16/75
&RQWDPLQDQWVIHHG'LUHFWLYH(&
z 2EOLJDWRU\FRQVXOWDWLRQRIWKH(XURSHDQ)RRG6DIHW\
$XWKRULW\()6$3DQHORQFRQWDPLQDQWVLQWKHIRRG
FKDLQEHIRUHSURYLVLRQVKDYLQJHIIHFWXSRQSXEOLF
KHDOWKRUDQLPDOKHDOWKRUWKHHQYLURQPHQWz 0L[LQJRISURGXFWVLQWHQGHGIRUDQLPDOIHHGQRW
FRPSO\LQJZLWKPD[LPXPOHYHOZLWKRWKHUSURGXFWV
LQWHQGHGIRUDQLPDOIHHGLQJIRUGLOXWLRQSXUSRVHVLVSURKLELWHG
z 'HWR[LILFDWLRQLVDOORZHGDOVRE\FKHPLFDOWUHDWPHQW
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 17/75
&RQWDPLQDQWVIHHG'LUHFWLYH(&
z VDIHJXDUGFODXVHDVFRQVHTXHQFHRIQHZLQIRUPDWLRQ
RUUHDVVHVVPHQWRIH[LVWLQJLQIRUPDWLRQ!VXVSLFLRQRI
FRQVWLWXWLQJDDQLPDORUKXPDQKHDOWKULVNDOWKRXJK
FRPSO\LQJ(8OHJLVODWLRQz LQWHUQDOPDUNHWQRUHVWULFWLRQRQSODFLQJRQWKHPDUNHW
IRUIHHGVFRPSO\LQJZLWK(8OHJLVODWLRQIRUUHDVRQV
UHODWLQJWRWKHLUFRQWDPLQDQWFRQWHQWz FRPSHWHQW6WDQGLQJ&RPPLWWHH6WDQGLQJ&RPPLWWHH
RQWKH)RRG&KDLQDQG$QLPDO+HDOWK
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 18/75
6HWWLQJUHJXODWRU\OLPLWVIRUFRQWDPLQDQWV±IHHG
z 6FLHQWLILFULVNDVVHVVPHQWDVVHVVPHQWRIWKHULVNVUHODWHGWRWKHSUHVHQFHRIDFRQWDPLQDQWLQIHHGIRU DQLPDODQGKXPDQKHDOWK
HVWDEOLVKPHQWRIDWR[LFH[SRVXUHOHYHOIRUGLIIHUHQWDQLPDOVSHFLHV±DQLPDOKHDOWK±VHQVLWLYHDQLPDOVSHFLHV
FDUU\RYHUIURPIHHGLQWRIRRGRIDQLPDORULJLQ±
TXDQWLWDWLYHO\±GLIIHUHQWDQLPDOVSHFLHVGLIIHUHQWDQLPDOSURGXFWV
ÆÆÆÆLVWKHEDVLVIRUWKHPHDVXUHVWREHWDNHQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 19/75
6HWWLQJUHJXODWRU\OLPLWVIRUFRQWDPLQDQWV±IHHG
z 'HWHUPLQDWLRQRIWKHIHHGPDWHULDOVZKLFKDUHLPSRUWDQWVRXUFHVRIFRQWDPLQDWLRQ
z 2FFXUUHQFHGDWDRIWKHFRQWDPLQDQWLQWKHYDULRXVIHHGPDWHULDOVIHHGV
z 6HWWLQJDPD[LPXPOHYHOVIRUIHHGPDWHULDOVDQGFRPSRXQGIHHGVWDNLQJLQWRDFFRXQWWKH
IDFWRUVPHQWLRQHGDERYHVHQVLWLYLW\DQLPDOVIHHGPDWHULDOVVRXUFHRIFRQWDPLQDWLRQ«DQGFRQVLGHULQJZKDWLVUHDVRQDEO\DFKLHYDEOH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 20/75
6HWWLQJUHJXODWRU\OLPLWV'HFLVLRQPDNLQJLQWKH(8
z 3URFHGXUH
± 'LVFXVVLRQRQPHDVXUHVWREHWDNHQZLWKH[SHUWVRIWKH0HPEHU6WDWHVLQWKH([SHUW
&RPPLWWHH³&RQWDPLQDQWV8QGHVLUDEOHVXEVWDQFHV´:RUNLQJSDUW\RIWKH6WDQGLQJ&RPPLWWHHRQWKH)RRG&KDLQDQG$QLPDO+HDOWK
± )LUVWLQIRUPDOVXEPLVVLRQRIGUDIWPHDVXUHFRQFHUQLQJFRQWDPLQDQWVWRWKH5HJXODWRU\FRPPLWWHH6WDQGLQJ&RPPLWWHHRQWKH)RRG&KDLQDQG$QLPDO+HDOWK
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 21/75
6HWWLQJUHJXODWRU\OLPLWV'HFLVLRQPDNLQJLQWKH(8
± 6WDNHKROGHUFRQVXOWDWLRQ
± LQWHUQDOFRQVXOWDWLRQRIGUDIWPHDVXUHZLWKLQ&RPPLVVLRQVHUYLFHVOHJDOVHUYLFH'*7UDGH'*$JULFXOWXUH'*(QWHUSULVH
± QRWLILFDWLRQRIGUDIWPHDVXUHWR:72 ± )RUPDOVXEPLVVLRQRIGUDIWPHDVXUHWR&RPPLWWHHIRU
RSLQLRQ±&RPPLWWHHH[SUHVVHVDQRSLQLRQ
± &RPPLVVLRQDGRSWVWKHPHDVXUHLQFDVHRIIDYRUDEOH
RSLQLRQTXDOLILHGPDMRULW\
± &RXQFLODGRSWVWKHPHDVXUHLQFDVHRIXQIDYRUDEOH
RSLQLRQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 22/75
,17(535(7$7,212)$1$/<7,&$/5(68/76
z 'HWDLOHGUHSRUWRQUHODWLRQVKLSDQDO\WLFDOUHVXOWVPHDVXUHPHQWXQFHUWDLQW\DQGUHFRYHU\KWWSHXURSDHXLQWFRPPIRRGIRRGFKHPLFDOVDIHW\FRQWDPLQDQWVUHSRUWVDPSOLQJBDQDO\VLVBBHQSGI
z 3URYLVLRQVRQKDUPRQL]HGLQWHUSUHWDWLRQRIDQDO\WLFDOUHVXOWVKDVEHHQLQWURGXFHGLQOHJLVODWLRQRQFRQWDPLQDQWVXQGHVLUDEOHVXEVWDQFHVIRRGIHHG
z $FRQVLJQPHQWLVFRQVLGHUHGDVQRQFRPSOLDQWLI
DQDO\WLFDOUHVXOWFRUUHFWHGIRUUHFRYHU\H[FHHGVWKHPD[LPXPOHYHOEH\RQGUHDVRQDEOHGRXEWWDNLQJLQWRDFFRXQWWKHPHDVXUHPHQWXQFHUWDLQW\
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 23/75
0\FRWR[LQVUHJXODWHGXQGHUFHUHDOV
z $IODWR[LQV ± UDZFHUHDOVDQGFHUHDOVFHUHDOSURGXFWVIRUGLUHFWKXPDQ
FRQVXPSWLRQRUIRRGLQJUHGLHQWZLWKWKHH[FHSWLRQRIUDZPDL]HJNJIRU$)%DQGJNJ$)727
± UDZPDL]HJNJIRU$)%DQGJNJ$)727z RFKUDWR[LQ$
± UDZFHUHDOJUDLQVLQFOXGLQJULFHDQGEXFNZKHDWJNJ
± DOOSURGXFWVGHULYHGIURPFHUHDOVLQFOXGLQJSURFHVVHGFHUHDO
SURGXFWVDQGFHUHDOJUDLQVLQWHQGHGIRUGLUHFWKXPDQFRQVXPSWLRQJNJ
z )XVDULXPWR[LQV'HR[\QLYDOHQRO]HDUDOHQRQHIXPRQLVLQV7DQG+7WR[LQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 24/75
3URYLVLRQV)XVDULXPWR[LQV)RRG
z 'HR[\QLYDOHQRO]HDUDOHQRQHIXPRQLVLQV%%DQG7+7 WR[LQ
z )RUWKHSXUSRVHRIWKHDSSOLFDWLRQRIWKH0/VIRU)XVDULXPWR[LQVULFHLVQRWLQFOXGHGLQ³FHUHDOV´DQG³FHUHDOSURGXFWV´
z 0L[LQJQRQFRPSO\LQJSURGXFWVZLWKFRPSO\LQJSURGXFWVLVSURKLELWHGDQGDOVRFKHPLFDOGHFRQWDPLQDWLRQLVSURKLELWHG
z 0HDVXUHVDSSOLFDEOHIURP
z 1RPD[LPXPOHYHOVIRUQLYDOHQRO$&'21$&'21
z 8QSURFHVVHGPDUNHWHGIRUILUVWVWDJHSURFHVVLQJ
z )LUVWVWDJHSURFHVVLQJDQ\SK\VLFDORUWKHUPDOWUHDWPHQWRWKHU WKDQGU\LQJRIRURQWKHJUDLQFOHDQLQJDQGVRUWLQJQRWFRQVLGHUHGDVILUVWVWDJHSURFHVVLQJ
z 5HYLHZRISURYLVLRQVIRUHVHHQE\-XO\
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 25/75
0D[LPXPOHYHOV)RRG)XVDULXPWR[LQV±'21
z 'HR[\QLYDOHQRO'21 ± XQSURFHVVHGFHUHDOVZLWKWKHH[FHSWLRQRIGXUXPZKHDWRDWV
DQGPDL]H JNJ
± 8QSURFHVVHGGXUXPZKHDWDQGRDWV JNJ
± 8QSURFHVVHGPDL]HIRUWKHWLPHEHLQJQR0/±HYHQWXDOO\JNJDSSOLFDEOHIURPRQZDUGVLIQRPD[LPXPOHYHOKDVEHHQHVWDEOLVKHGLQWKHPHDQWLPH
± &HUHDO)ORXULQFOXGLQJPDL]HIORXUPDL]HJULWVDQGPDL]HPHDOJNJ
± %UHDGSDVWULHVELVFXLWVFHUHDOVQDFNVDQGEUHDNIDVWFHUHDOV
JNJ ± 3DVWDGU\ JNJ
± 3URFHVVHGFHUHDOEDVHGIRRGIRULQIDQWVDQG\RXQJFKLOGUHQDQGLQJUHGLHQWVIRUWKHPDQXIDFWXUHRIWKHVHSURGXFWVJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 26/75
0D[LPXPOHYHOVIRRG)XVDULXPWR[LQV=($
z =HDUDOHQRQH ± XQSURFHVVHGFHUHDOVZLWKWKHH[FHSWLRQRIXQSURFHVVHGPDL]H
JNJ
± XQSURFHVVHGPDL]HIRUWKHWLPHEHLQJQR0/±HYHQWXDOO\JNJDSSOLFDEOHIURPRQZDUGVLIQRPD[LPXPOHYHO
KDVEHHQHVWDEOLVKHG
± &HUHDO)ORXUH[FHSWPDL]HIORXU JNJ
± 0DL]HIORXUPDL]HPHDOPDL]HJULWVDQGUHILQHGPDL]HRLOIRUWKH
WLPHEHLQJQR0/±HYHQWXDOO\JNJDSSOLFDEOHIURP
RQZDUGVLIQRPD[LPXPOHYHOKDVEHHQHVWDEOLVKHGLQ
WKHPHDQWLPH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 27/75
0D[LPXPOHYHOVIRRG)XVDULXPWR[LQV=($
± %UHDGSDVWULHVELVFXLWV JNJ
± 0DL]HVQDFNVDQGPDL]HEDVHGEUHDNIDVWFHUHDOVIRUWKHWLPH
EHLQJQR0/±HYHQWXDOO\JNJDSSOLFDEOHIURP
RQZDUGVLIQRPD[LPXPOHYHOKDVEHHQHVWDEOLVKHGLQWKH
PHDQWLPH ± 2WKHUFHUHDOVQDFNVDQGEUHDNIDVWFHUHDOVJNJ
± 3URFHVVHGPDL]HEDVHGIRRGIRULQIDQWVDQG\RXQJFKLOGUHQDQG
LQJUHGLHQWVIRUWKHPDQXIDFWXUHRIWKHVHSURGXFWVIRUWKHWLPH
EHLQJQR0/±HYHQWXDOO\JNJDSSOLFDEOHIURPRQZDUGVLIQRPD[LPXPOHYHOKDVEHHQHVWDEOLVKHGLQWKH
PHDQWLPH
± 2WKHUSURFHVVHGFHUHDOEDVHGIRRGIRULQIDQWVDQG\RXQJ
FKLOGUHQDQGLQJUHGLHQWVIRUWKHPDQXIDFWXUHRIWKHVHSURGXFWV
JNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 28/75
0D[LPXPOHYHOV)RRG)XVDULXPWR[LQV±)%)%
z )XPRQLVLQ%% ± 1RPD[LPXPOHYHOHVWDEOLVKHGIRUWKHWLPH
EHLQJ±LIQRVSHFLILFOHYHOLVIL[HGEHIRUH
2FWREHUWKHIROORZLQJOHYHOVZLOODSSO\z XQSURFHVVHGPDL]HJNJ
z 0DL]HJULWVPDL]HPHDOPDL]HIORXUDQGUHILQHGPDL]HVHPROLQDJNJ
z PDL]HEDVHGIRRGIRULQIDQWVDQG\RXQJFKLOGUHQDQGEDE\IRRGJNJRQGU\PDWWHUEDVLV
z 2WKHUPDL]HEDVHGIRRGVIRUGLUHFWKXPDQFRQVXPSWLRQJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 29/75
0D[LPXPOHYHOV)RRG)XVDULXPWR[LQV7+7
z 7+7WR[LQ
± 5HOLDEOHRFFXUUHQFHGDWDYHU\OLPLWHG
± 2FFXUVLQSDUWLFXODULQRDWV
± 1RLQWHUQDWLRQDOO\YDOLGDWHGPHWKRGVRIDQDO\VLV
± )RUWKHWLPHEHLQJQR0/SURSRVHG
± )RUHVHHQWRLIDSSURSULDWHWRHVWDEOLVK
PD[LPXPOHYHOVIRU7DQG+7WR[LQE\
DWWKHODWHVW
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 30/75
5HFRPPHQGDWLRQ)HHG)RRG3UHYHQWLRQ)XVDULXPWR[LQV
z 5HFRPPHQGDWLRQ(&RI$XJXVWRQWKHSUHYHQWLRQDQGUHGXFWLRQRI)XVDULXP±WR[LQVLQFHUHDOVDQGFHUHDOSURGXFWV
± 5LVNIDFWRUVWREHFRQVLGHUHGIRULQFOXVLRQLQ*RRG
$JULFXOWXUDO3UDFWLFHV*$3 ± &RQWDPLQDWLRQE\)XVDULXPWR[LQVRIFHUHDOVFDQEH
LPSXWHGWRPXOWLSOHIDFWRUV
± LQWHJUDWHGDSSURDFKDGGUHVVLQJLQDUHDVRQHGZD\DOOSRVVLEOHULVNIDFWRUVWDNLQJLQWRDFFRXQWWKHORFDO
VLWXDWLRQÆÆÆÆWREHLPSOHPHQWHGE\WKHGHYHORSPHQWRI QDWLRQDOFRGHVRISUDFWLFHEDVHGRQWKHVHSULQFLSOHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 31/75
3URYLVLRQVP\FRWR[LQV)(('
z 0D[LPXPOHYHOVHVWDEOLVKHGLQ$QQH[WR'LUHFWLYH(&
z 0D[LPXPOHYHOVDUHUHODWLYHWRDIHHGLQJVWXIIZLWKDPRLVWXUHFRQWHQWRI
z 3URKLELWLRQRIPL[LQJQRQFRPSO\LQJZLWKFRPSO\LQJEDWFKHVDQGSURKLELWLRQRQGLOXWLRQ
z &KHPLFDOGHWR[LILFDWLRQDOORZHG
z 0D[LPXPOHYHOVIRUDIODWR[LQ%DQGU\HHUJRW
z 6DPSOLQJDFFRUGLQJ'LUHFWLYH(&HVWDEOLVKLQJWKHVDPSOLQJSURFHGXUHVWREHDSSOLHGLQIHHGIRU RIILFLDOFRQWURO
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 32/75
0\FRWR[LQVDQLPDOIHHGDIODWR[LQ%PD[LPXPOHYHOV
z $OOIHHGPDWHULDOV JNJ
z &RPSOHWHIHHGIRUFDWWOHVKHHSDQGJRDWV JNJ
± H[FHSWFRPSOHWHIHHGIRUGDLU\DQLPDOV JNJ
H[FHSWFRPSOHWHIHHGIRUFDOYHVDQGODPEV JNJ
z &RPSOHWHIHHGIRUSLJVDQGSRXOWU\ JNJ
± H[FHSWFRPSOHWHIHHGIRU\RXQJDQLPDOV JNJ
z 2WKHUFRPSOHWHIHHGV JNJ
z &RPSOHPHQWDU\IHHGIRUFDWWOHVKHHSJRDWVSLJVDQGSRXOWU\
JNJ ± ([FHSWFRPSOHPHQWDU\IHHGIRUFDWWOHVKHHSJRDWV
± \RXQJDQLPDOVRISLJVDQGSRXOWU\
z 2WKHUFRPSOHPHQWDU\IHHGLQJVWXIIV JNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 33/75
$IODWR[LQ%)ROORZXS()6$RSLQLRQ
z ()6$XSGDWHGULVNDVVHVVPHQWRQDIODWR[LQ%
z )ROORZXS()6$RSLQLRQ
± 0RQLWRULQJRIDIODWR[LQ%LQIHHGPDWHULDOVFRQWLQXHGDQGLQWHQVLILHGIHHGLQJVWXIIVIRUGDLU\DQLPDOVRWKHUWKDQGDLU\
FRZVVKRXOGJHWSDUWLFXODUDWWHQWLRQ
± $IODWR[LQ0WREHPRQLWRUHGRQPLONDWIDUPOHYHO
± 1RQHHGWRFKDQJHFXUUHQW0/¶V0/PD[LPXPOHYHO
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 34/75
0\FRWR[LQVDQLPDOIHHGU\HHUJRW
z $OOIHHGLQJVWXIIVFRQWDLQLQJXQJURXQGFHUHDOVJUDPVFOHURWLDNJIHHG
z ()6$RSLQLRQ$SULO ± DGYHUVHHIIHFWVPD\RFFXUDWFRQFHQWUDWLRQVFORVHWRWKDW
OHYHOLQIDUPDQLPDOVSDUWLFXODUO\LQSLJV ± QRVXIILFLHQWVFLHQWLILFLQIRUPDWLRQDYDLODEOHDWWKLV
PRPHQWWRGHWHUPLQHLQGLFDWRUHUJRWDONDORLGV
z 5HFRPPHQGDWLRQRIPRQLWRULQJRIFHUHDOVDQGFHUHDO
SURGXFWVIRUKXPDQFRQVXPSWLRQDQGDQLPDOIHHGLQJRIDWOHDVWHUJRFULVWLQHHUJRWDPLQHHUJRFU\SWLQHHUJRPHWULQHHUJRVLQHDQGHUJRFRUQLQHUHODWLRQVFOHURWLDLQGLYLGXDOHUJRWDONDORLGFRQWHQW
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 35/75
0\FRWR[LQV)HHG
z ()6$RSLQLRQVRQGHR[\QLYDOHQRO-XQH]HDUDOHQRQH-XO\IXPRQLVLQV-XQHRFKUDWR[LQ$6HSWHPEHU
z $QLPDOKHDOWKHIIHFWVFULWLFDOHIIHFWV±LPSDFWSXEOLFKHDOWKPLQRU
DVFDUU\RYHUIURPIHHGWRIRRGLVOLPLWHGz 7ZRVWHSDSSURDFK&RPPLVVLRQ5HFRPPHQGDWLRQRI
$XJXVWRQLQFUHDVHGPRQLWRULQJFRPELQHGZLWKJXLGDQFHRULHQWDWLRQYDOXHVDVILUVWVWHS±HYDOXDWLRQE\RI WKHHIIHFWLYHQHVVRIWKHDSSURDFKLQYLHZRIWKHFRQVLGHUDWLRQRI
SRVVLEOHIXUWKHUOHJDOPHDVXUHVLQWKHIUDPHRI'LUHFWLYH(&
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 36/75
0\FRWR[LQV)HHG'HR[\QLYDOHQRO'21
z ()6$RSLQLRQ ± )RRGVRIDQLPDORULJLQFRQWULEXWHRQO\PDUJLQDOO\WRWRWDO
KXPDQ'21H[SRVXUH
± 3LJVPRVWVHQVLWLYH±PJNJUHSRUWHGDVQHJDWLYH
HIIHFWRQIHHGLQWDNH ± +HDOWK\DGXOWUXPLQDQWVPRVWWROHUDQWWR'21
z 5HFRPPHQGHGJXLGDQFHYDOXHV ± &HUHDOVDQGFHUHDOSURGXFWV SSP
± 0DL]HE\SURGXFWV SSP ± &RPSOHPHQWDU\DQGFRPSOHWHIHHG SSPz ([FHSWIRUSLJV SSP
z ([FHSWIRUFDOYHVODPEVDQGNLGV SSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 37/75
0\FRWR[LQV)HHG=HDUDOHQRQH=($
z ()6$RSLQLRQ ± )RRGVRIDQLPDORULJLQFRQWULEXWHRQO\PDUJLQDOO\WRWRWDO
KXPDQ=($H[SRVXUH
± )HPDOHSLJVPRVWVHQVLWLYHVKHHSDOVRTXLWHVHQVLWLYH
± &DWWOHOHVVVHQVLWLYHSRXOWU\QRWVHQVLWLYHz 5HFRPPHQGHGJXLGDQFHYDOXHV
± &HUHDOVDQGFHUHDOSURGXFWV SSP
± 0DL]HE\SURGXFWV SSP
± &RPSOHPHQWDU\DQGFRPSOHWHIHHGz )RUSLJOHWVDQGJLOWV\RXQJVRZV SSP
z )RUVRZVDQGIDWWHQLQJSLJV SSP
z )RUFDOYHVGDLU\FDWWOHVKHHSDQGJRDWV SSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 38/75
0\FRWR[LQV)HHGRFKUDWR[LQ$27$
z ()6$RSLQLRQ
± )RRGVRIDQLPDORULJLQFRQWULEXWHRQO\WRDPLQRUH[WHQWWR
WRWDOKXPDQ27$H[SRVXUH
± 3LJVPRVWVHQVLWLYHSRXOWU\DOVRVHQVLWLYH ± 2WKHUDQLPDOVSHFLHVQRWVHQVLWLYH
z 5HFRPPHQGHGJXLGDQFHYDOXHV
± &HUHDOVDQGFHUHDOSURGXFWV SSP
± &RPSOHPHQWDU\DQGFRPSOHWHIHHG
z )RUSLJV SSP
z )RUSRXOWU\ SSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 39/75
0\FRWR[LQV)HHG)XPRQLVLQ%%
z ()6$RSLQLRQ
± &DUU\RYHURIIXPRQLVLQVIURPDQLPDOIHHGVLQWRHGLEOH
WLVVXHVLQFOXGLQJPLONDQGHJJVOLPLWHGDQGFRQVHTXHQWO\
SURGXFWVRIDQLPDORULJLQGRQRWFRQWULEXWHVXEVWDQWLDOO\
WRKXPDQH[SRVXUH
± )XPRQLVLQVH[KLELWWR[LFHIIHFWVLQDOODQLPDOVSHFLHV
± 3LJVDQGKRUVHVWKHPRVWVHQVLWLYHDQLPDOVSHFLHVDOVR
UDEELWVVHQVLWLYH ± %URLOHUVOHVVVHQVLWLYH
± $GXOWUXPLQDQWVQRWVHQVLWLYH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 40/75
0\FRWR[LQV)HHG)XPRQLVLQ%%
z 5HFRPPHQGHGJXLGDQFHYDOXHV
± 0DL]HDQGPDL]HSURGXFWV SSP
± &RPSOHPHQWDU\DQGFRPSOHWHIHHG
z )RUSLJVKRUVHVUDEELWVDQGSHWDQLPDOV SSP
z )LVK SSP
z 3RXOWU\FDOYHVODPEVDQGNLGV SSP
z $GXOWUXPLQDQWVDQGPLQN SSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 41/75
0\FRWR[LQV)HHG*XLGDQFHYDOXHV
z 6SHFLILFSURYLVLRQIRUFHUHDOVDQGFHUHDOSURGXFWVGLUHFWO\IHGWRDQLPDOV
z &HUHDOVDQGFHUHDOSURGXFWVLQFOXGHDOVRFHUHDOIRUDJHVDQGURXJKDJHV0DL]HDQGPDL]HSURGXFWVLQFOXGHDOVRPDL]HIRUDJHV
DQGURXJKDJHVz *XLGDQFHYDOXHVWREHXVHGE\IHHGEXVLQHVVRSHUDWRUVDV
JXLGDQFHIRUWKHGHWHUPLQDWLRQRIFULWLFDOOLPLWVLQWKHLU+$&&3V\VWHPZKLFKVHSDUDWHDFFHSWDELOLW\IURPXQDFFHSWDELOLW\IRUWKHSUHYHQWLRQHOLPLQDWLRQRUUHGXFWLRQRILGHQWLILHGKD]DUGV±
DWWHQWLRQIRUFHUHDOVDQGFHUHDOSURGXFWVIRUWKHSURGXFWLRQRIIHHGIRUVHQVLWLYHDQLPDOVSHFLHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 42/75
0\FRWR[LQV)HHG*XLGDQFHYDOXHV
z *XLGDQFHYDOXHVIRUFHUHDOVDQGFHUHDOSURGXFWVKDYHEHHQGHWHUPLQHGIRUWKHPRVWWROHUDQWDQLPDOVSHFLHVDQGDUHWKHUHIRUHWREHFRQVLGHUHGDVXSSHUJXLGDQFHYDOXHV
z 7KHUHIRUHIRUWKHSURGXFWLRQRIIHHGIRUPRUHVHQVLWLYHDQLPDOVORZHUJXLGDQFHYDOXHVDUHWREHDSSOLHGE\WKHIHHGPDQXIDFWXUHUVWDNLQJLQWRDFFRXQWWKHVHQVLWLYLW\
RIWKHDQLPDOVSHFLHVDQGHQDEOLQJFRPSOLDQFHZLWKWKHJXLGDQFHYDOXHVGHWHUPLQHGIRUWKHFRPSRXQGIHHGLQJVWXIIIRUWKDWDQLPDO
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 43/75
(8VWUDWHJ\ ±GLR[LQVDQG3&%V
z &RPSUHKHQVLYHVHWRIPHDVXUHVWROLPLWWKHWKHSUHVHQFHRIGLR[LQVLQHQYLURQPHQWIHHGDQGIRRG
z 0HDVXUHVLQIHHGDQGIRRGFRQVLVWRIWKUHHSLOODUV ± PD[LPXPOHYHOV
± DFWLRQOHYHOV
± WDUJHWOHYHOV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 44/75
)LUVWSLOODUIHHGDQGIRRG0D[LPXPOHYHOV
z IRUUHJXODWRU\FRQWURO
z KLJKO\FRQWDPLQDWHGSURGXFWVDUHQRWDOORZHGWREHSXWRQWKHPDUNHWRUKDYHWREH
ZLWKGUDZQIURPWKHPDUNHWz WUDQVSDUHQW
z HQVXULQJXQLIRUPDSSOLFDWLRQRIOHJLVODWLRQ
DFURVVWKH(8z HVWDEOLVKHGDWDVWULFWEXWIHDVLEOHOHYHO
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 45/75
6HFRQGSLOODUIHHGDQGIRRG$FWLRQOHYHOV
z HDUO\ZDUQLQJWRROIRUFRPSHWHQWDXWKRULWLHV
DQGRSHUDWRUV
z WULJJHULQJDFWLRQRQLGHQWLILFDWLRQRIVRXUFHV
DQGSDWKZD\VRIFRQWDPLQDWLRQ
z SURDFWLYHDSSURDFKWRUHGXFHWKHSUHVHQFHRI
GLR[LQVLQIRRGDQGIHHGz LQWHUDFWLRQZLWKHQYLURQPHQWDOPHDVXUHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 46/75
7KLUGSLOODUIHHGDQGIRRG7DUJHWOHYHOV
z WDUJHWOHYHOVLQGLFDWHWKHOHYHOVWREHDFKLHYHG
RYHUWLPHLQIHHGDQGIRRGLQRUGHUWRXOWLPDWHO\
EULQJKXPDQH[SRVXUHIRUWKHPDMRULW\RIWKH
(8SRSXODWLRQGRZQWRRUEHORZWKH7:,IRU
GLR[LQVIXUDQVDQGGLR[LQOLNH3&%V
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 47/75
/HJLVODWLRQVLQFH)HHGDQG)RRG
z PD[LPXPOHYHOVDQGDFWLRQOHYHOVHVWDEOLVKHGLQRQO\IRU3&'')
z UHTXLUHPHQWVDVUHJDUGVVDPSOLQJDQGPHWKRGVRI
DQDO\VLVVFUHHQLQJDQGFRQILUPDWRU\SXUSRVHVz DFWLYHDSSURDFKWRHVWDEOLVKDFRPSUHKHQVLYH
GDWDEDVHRQWKHSUHVHQFHRIGLR[LQOLNH3&%V
z (VWDEOLVKPHQWRIPD[LPXPOHYHOVIRUWRWDO7(4YDOXHV
3&''3&')'/3&%VDQGDFWLRQOHYHOVVHSDUDWHO\IRU3&'')DQGIRU'/3&%6LQDSSOLFDEOHIURP1RYHPEHU
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 48/75
0D[LPXPOHYHOV)HHG
z DOOOHYHOVUHODWLYHWRDIHHGLQJVWXIIZLWKDPRLVWXUHFRQWHQWRI
z XSSHUERXQGOHYHOVQRQTXDQWLILHGFRQJHQHUVHTXDOWROLPLWRITXDQWLILFDWLRQ
z OHYHOVDUHH[SUHVVHGDVQJ:+23&'')7(4NJIRU GLR[LQVDQGIXUDQVDQGDVQJ:+23&'')3&%7(4NJIRUWKHVXPRIGLR[LQVIXUDQVDQG3&%V7()
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 49/75
0D[LPXPOHYHOV
'LR[LQVDQG'/3&%V'LUHFWLYH(&
z ([LVWLQJOHYHOGLR[LQVDQGIXUDQV±QHZOHYHOV
IRUVXPRIGLR[LQVIXUDQVDQG'/3&%V
± )HHGPDWHULDOVRISODQWRULJLQ±QJNJ
± 9HJHWDEOHRLOVDQGE\SURGXFWV±QJNJ
± )HHGPDWHULDOVRIPLQHUDORULJLQ±QJNJ
± $QLPDOIDW±QJNJ
± 2WKHUODQGDQLPDOSURGXFWV±QJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 50/75
0D[LPXPOHYHOV
'LR[LQVDQG'/3&%V'LUHFWLYH(&
z ([LVWLQJOHYHOGLR[LQVDQGIXUDQV±QHZOHYHOV
IRUVXPRIGLR[LQVIXUDQVDQG'/3&%V
± )LVKRLO±QJNJ
± )LVKPHDO±QJNJ
± )LVKSURWHLQK\GURO\VDWHVQJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 51/75
0D[LPXPOHYHOV
'LR[LQVDQG'/3&%V'LUHFWLYH(&
z /HYHOGLR[LQVDQGIXUDQV±QHZOHYHOVIRUVXPRIGLR[LQVIXUDQVDQG'/3&%V ± $GGLWLYHVEHORQJLQJWRWKHIXQFWLRQDOJURXSRI
ELQGHUVDQGDQWLFDNLQJDJHQWVQJNJ ± $GGLWLYHVEHORQJLQJWRWKHIXQFWLRQDOJURXSRI
WUDFHHOHPHQWV±QJNJ
± 3UHPL[WXUHV±QJNJOHYHOGLR[LQVRQO\DSSOLFDEOHWRNDROLQLWLFFOD\FDOFLXPVXOSKDWH
GLK\GUDWHYHUPLFXOLWHQDWUROLWHSKRQROLWHV\QWKHWLFFDOFLXPDOXPLQDWHVDQGFOLQRSWLOROLWHRIVHGLPHQWDU\RULJLQ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 52/75
0D[LPXPOHYHOV
'LR[LQVDQG'/3&%V'LUHFWLYH(&
z /HYHOGLR[LQVDQGIXUDQV±QHZOHYHOVIRUVXP
RIGLR[LQVIXUDQVDQG'/3&%V
± &RPSRXQGIHHGZLWKH[FHSWLRQRIIHHGIRUIXU
DQLPDOVSHWIRRGVDQGILVKIHHG±QJNJ
± )LVKIHHGDQGSHWIRRGV±QJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 53/75
0D[LPXPOHYHOVIHHG6SHFLILFSURYLVLRQV
z $VUHJDUGVILVKRLOHIIRUWVKDYHWREHGRQHE\WKH
RSHUDWRUVWRLQFUHDVHWKHFDSDFLW\WRUHPRYHHIIHFWLYHO\
GLR[LQVIXUDQVDQGGLR[LQOLNH3&%VIURPILVKRLO
z $VUHJDUGVILVKPHDODQGILVKSURWHLQK\GURO\VDWHVHIIRUWVKDYHWREHGRQHE\WKHRSHUDWRUVWRLQYHVWLJDWH
WKHSRVVLELOLWLHVWRUHPRYHGLR[LQVIXUDQVDQGGLR[LQ
OLNH3&%VIURPILVKPHDODQGILVKSURWHLQK\GURO\VDWHV
DQGWRKDYHVXIILFLHQWGHFRQWDPLQDWLRQFDSDFLW\
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 54/75
0D[LPXPOHYHOVIHHG6SHFLILFSURYLVLRQV
z $UHYLHZRIWKHPD[LPXPOHYHOVZLWKWKHDLPRI VLJQLILFDQWO\UHGXFLQJRIWKHPD[LPXPOHYHOVLVIRUHVHHQE\'HFHPEHU$VUHJDUGVILVKRLOILVKPHDODQGILVKSURWHLQK\GURO\VDWHVWKLVVLJQLILFDQW
ORZHUOHYHOVKDOOEHGHWHUPLQHGEDVHGRQWKHWHFKQLFDOSRVVLELOLWLHVRIWKHPRVWHIIHFWLYHHFRQRPLFDOO\YLDEOHGHFRQWDPLQDWLRQSURFHGXUH
z 5HYLVLRQRIWKHPD[LPXPOHYHOVE\'HFHPEHUZLWKWKHDLPRIVLJQLILFDQWO\UHGXFLQJWKHPD[LPXPOHYHOVIRUWKHVXPRIGLR[LQVDQGGLR[LQOLNH3&%V
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 55/75
$FWLRQOHYHOV
z 6HSDUDWHDFWLRQOHYHOVIRUGLR[LQVDQGIXUDQV
RQWKHRQHKDQGDQGGLR[LQOLNH3&%VRQWKH
RWKHUKDQGJLYHQWKHGLIIHUHQWVRXUFHVRI
GLR[LQVDQGGLR[LQOLNH3&%V
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 56/75
$FWLRQOHYHOV±)HHG'LU(&±'LU(&
3&'')'/3&%VQJNJ
z IHHGPDWHULDOVRISODQWRULJLQZLWKWKHH[FHSWLRQRI YHJHWDEOHRLOVDQGIDWV QJNJ
z
YHJHWDEOHRLOVDQGIDWV QJNJz IHHGPDWHULDOVRIPLQHUDORULJLQ QJNJ
z DQLPDOIDWLQFOXGLQJPLONDQGHJJIDW QJNJ
z DQLPDOE\SURGXFWV QJNJ
z ILVKRLO QJNJ
z ILVKPHDO QJNJ
z ILVKSURWHLQK\GURO\VDWHV!IDW QJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 57/75
$FWLRQOHYHOV±)HHG'LU(&±'LU(&
z DGGLWLYHV±ELQGHUVDQGDQWLFDNLQJDJHQWVQJNJ
z DGGLWLYHV±WUDFHHOHPHQWV QJNJ
z SUHPL[WXUHV QJNJ
z FRPSRXQGIHHGLQJVWXIIV QJNJ
± H[FHSWILVKIHHG
± H[FHSWIHHGLQJVWXIIVIRUIXUDQLPDOV
± H[FHSWIHHGLQJVWXIIVIRUSHWDQLPDOVz IHHGLQJVWXIIVIRUILVKDQGSHWIRRG QJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 58/75
/HDG5HFHQWFKDQJHV&RP'LU(&
z &XUUHQWPD[LPXPOHYHOV ± )HHGPDWHULDOVSSPZLWKWKHH[FHSWLRQRIJUHHQIRGGHU
SSPSKRVSKDWHVDQGFDOFDUHRXVPDULQHDOJDHSSPFDOFLXPFDUERQDWHSSPDQG\HDVWVSSP
± &RPSOHPHQWDU\IHHGLQJVWXIIVSSPZLWKWKHH[FHSWLRQRI PLQHUDOIHHGLQJVWXIIVSSP
± &RPSOHWHIHHGLQJVWXIIVSSP
z )ROORZXSRI()6$RSLQLRQ-XQH
± &DUU\RYHULQPLONORZORZOHYHOVLQPHDWÆIRRGRIDQLPDORULJLQQRPDMRUVRXUFHRIKXPDQH[SRVXUHWROHDG
± &DWWOHVKHHSPRVWVHQVLWLYHVSHFLHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 59/75
/HDG5HFHQWFKDQJHV&RP'LU(&
z 1HZSURYLVLRQVDSSOLFDEOHDVIURP ± 0/LQJUHHQIRGGHUÆUHGXFHGIURPSSPWRSSP
± 0/7UDFHHOHPHQWVSSPZLWKWKHH[FHSWLRQ]LQFR[LGHSSPDQGPDQJDQRXVR[LGHLURQFDUERQDWHDQGFRSSHU FDUERQDWHSSP
± 0/ELQGHUVDQGDQWLFDNLQJDJHQWVSSPH[FHSWFOLQRSWLOROLWHRIYROFDQLFRULJLQSSP
± 3UHPL[WXUHVSSPLQVWUXFWLRQVIRUXVHDUHLQDFFRUGDQFHZLWKWKHPD[LPXPOHYHOVIRUFRPSOHPHQWDU\DQGFRPSOHWH
IHHGLQJVWXIIV ± ([WUDFWLRQSURFHGXUHIRUDQDO\VLVGHILQHGQLWULFDFLGZZIRUPLQDWERLOLQJWHPSHUDWXUHHTXLYDOHQWSURFHGXUHVFDQEHDSSOLHG
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 60/75
&DGPLXP5HFHQWFKDQJHV&RP'LU(&
z &XUUHQWPD[LPXPOHYHOV ± )HHGPDWHULDOVRIYHJHWDEOHRULJLQSSP
± )HHGPDWHULDOVRIDQLPDORULJLQSSPZLWKWKHH[FHSWLRQRI IHHGLQJVWXIIVIRUSHWV
± 3KRVSKDWHVSSP ± &RPSOHPHQWDU\IHHGLQJVWXIIVIRUFDWWOHVKHHSDQGJRDWVSSP
± 0LQHUDOIHHGLQJVWXIIVSSP
± &RPSOHWHIHHGLQJVWXIIVIRUFDWWOHVKHHSDQGJRDWVSSPZLWKWKHH[FHSWLRQRIFRPSOHWHIHHGLQJVWXIIVIRUFDOYHVODPEVDQGNLGV
SSP ± 2WKHUFRPSOHWHIHHGLQJVWXIIVSSPZLWKWKHH[FHSWLRQRI
IHHGLQJVWXIIVIRUSHWV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 61/75
/HDG5HFHQWFKDQJHV&RP'LU(&
z )ROORZXSRI()6$RSLQLRQ-XQH
± $FFXPXODWLRQLQNLGQH\VRIUXPLQDQWVDQGKRUVHV
± 3LJVPRVWVHQVLWLYHVSHFLHVDQLPDOKHDOWK
± ([LVWLQJ0/VDUHDSSURSULDWH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 62/75
/HDG5HFHQWFKDQJHV&RP'LU(&
z 1HZSURYLVLRQVDSSOLFDEOHDVIURP
± 0/7UDFHHOHPHQWVSSPZLWKWKHH[FHSWLRQFRSSHUR[LGH]LQFR[LGHPDQJDQRXVR[LGHDQGPDQJDQRXVVXOSKDWHPRQRK\GUDWHSSP
± 0/ELQGHUVDQGDQWLFDNLQJDJHQWVSSP ± 3UHPL[WXUHVSSPLQVWUXFWLRQVIRUXVHDUHLQDFFRUGDQFHZLWK
WKHPD[LPXPOHYHOVIRUFRPSOHPHQWDU\DQGFRPSOHWHIHHGLQJVWXIIV
± 0LQHUDOIHHGLQJVWXIIVSSPLIFRQWDLQLQJOHVVWKDQ
SKRVSKRUXVDQGSSPSHUSKRVSKRUXVIRUPLQHUDOIHHGLQJVWXIIVFRQWDLQLQJPRUHWKDQSKRVSKRUXVZLWKDPD[LPXPRISSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 64/75
/HDG5HFHQWFKDQJHV&RP'LU(&
z )ROORZXSRI()6$RSLQLRQ ± &DUU\RYHULQWRHGLEOHWLVVXHVLQFOXGLQJPLONDQGHJJVLV
OLPLWHG
± ([LVWLQJ0/VDUHDSSURSULDWH
z 1HZSURYLVLRQVDSSOLFDEOHDVIURP
± 0/PDULQHFUXVWDFHDQVVXFKDVPDULQHNULOOSSP
± 0/YHUPLFXOLWHSSP
± ([WUDFWLRQSURFHGXUHIRUDQDO\VLVGHILQHGK\GURFKORULFDFLG1IRUPLQXWHVDWDPELHQWWHPSHUDWXUH±HTXLYDOHQW
SURFHGXUHVFDQEHDSSOLHG
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 65/75
&DPSKHFKORU±5HFHQWFKDQJHV&RP'LU(&
z ([LVWLQJPD[LPXPOHYHO
± DOOIHHGLQJVWXIIVPJNJWRWDOFDPSKHFKORU
z ()6$±RSLQLRQ)HEUXDU\
± )LVKPRVWVHQVLWLYHVSHFLHV
± &DUU\RYHURIFDPSKHFKORULQWRHGLEOHWLVVXHVRI
IDWW\ILVKLVKLJK
± )LVKLVPDLQVRXUFHRIKXPDQH[SRVXUH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 66/75
&DPSKHFKORU±5HFHQWFKDQJHV&RP'LU(&
z 1HZSURYLVLRQVDSSOLFDEOHDVIURP
± 'HILQLWLRQRIPD[LPXPOHYHOVXPRI&+%RU
3DUODUDQG
± /LPLWLQJ0/VWRILVKRLOILVKPHDODQGILVKIHHGDVEHLQJLGHQWLILHGDVWKHPDLQVRXUFHVRI
FDPSKHFKORUH[SRVXUHRIIDUPHGDQLPDOV
± ILVKRLOPJNJILVKPHDOPJNJDQGILVKIHHGPJNJ
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 67/75
$UVHQLF)ROORZXS()6$RSLQLRQ
z $UVHQLF$V
± $OODQLPDOVSHFLHVVHQVLWLYHWRLQRUJDQLFDUVHQLF
± 2UJDQLF$VPXFKOHVVWR[LFWKDQLQRUJDQLF$V
± 0HWKRGRIDQDO\VLVIRULQRUJDQLFDUVHQLFWREH
HODERUDWHGDQGYDOLGDWHGXUJHQWO\
± )XWXUH0/IRULQRUJDQLFDUVHQLFRQO\
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 68/75
(QGRVXOIDQ)ROORZXS()6$RSLQLRQ
z ()6$RSLQLRQ-XQH ± H[LVWLQJOHJDOSURYLVLRQVDVUHJDUGVHQGRVXOIDQLQSURGXFWV
LQWHQGHGIRUDQLPDOIHHGLQFOXGLQJWKHVWULFWOHYHOIRUILVKIHHGDUHDSSURSULDWHWRHQVXUHWKDWWKHVHSURGXFWVGRQRWUHSUHVHQWDQ\GDQJHUWRKXPDQKHDOWKDQLPDOKHDOWKRU
DGYHUVHO\DIIHFWWKHOLYHVWRFNSURGXFWLRQz &RPPLVVLRQ'LUHFWLYH(&DSSOLFDEOHDVIURP
RLOVHHGVDQGSURGXFWVGHULYHGIURPWKHSURFHVVLQJWKHUHRI
ZLWKWKHH[FHSWLRQRIFUXGHYHJHWDEOHRLOSSPH[LVWLQJOHYHO
FUXGHYHJHWDEOHRLOSSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 69/75
$OGULQGLHOGULQ)ROORZXS()6$RSLQLRQ
z ()6$RSLQLRQ-XQH ± H[LVWLQJOHJDOSURYLVLRQVDVUHJDUGVDOGULQDQGGLHOGULRQ
QHHGHGWREHDPHQGHGLQRUGHUWRWDNHDFFRXQWRI EDFNJURXQGSUHVHQFHEXWHQVXULQJWKDWWKHVHSURGXFWVGRQRWUHSUHVHQWDQ\GDQJHUWRKXPDQKHDOWKDQLPDOKHDOWKRU
DGYHUVHO\DIIHFWWKHOLYHVWRFNSURGXFWLRQz &RPPLVVLRQ'LUHFWLYH(&DSSOLFDEOHDVIURP
)RURLOVDQGIDWVWKHOHYHOKDVEHHQLQFUHDVHGIURPSSP
WRSSP 7KHOHYHOIRUDOORWKHUIHHGLQJVWXIIVKDVUHPDLQHGWKHVDPHSSPH[FHSWIRUILVKIHHGLQFUHDVHGWRSSP
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 70/75
+&+ĮȕȖLVRPHUVHQGULQ)ROORZXS()6$RSLQLRQ
z ()6$RSLQLRQDQGHQGULQ ± H[LVWLQJOHJDOSURYLVLRQVDVUHJDUGV+&+ĮȕȖLVRPHUV
DQGHQGULQLQSURGXFWVLQWHQGHGIRUDQLPDOIHHGDUH
DSSURSULDWHWRHQVXUHWKDWWKHVHSURGXFWVGRQRWUHSUHVHQW
DQ\GDQJHUWRKXPDQKHDOWKDQLPDOKHDOWKRUDGYHUVHO\DIIHFWWKHOLYHVWRFNSURGXFWLRQ
z &RPPLVVLRQ'LUHFWLYH(&
± 1RFKDQJHVWRH[LVWLQJOHYHOVQHHGHG
)XWXUHGLVFXVVLRQV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 71/75
8QGHVLUDEOHVXEVWDQFHV)HHG
z 1RQGLR[LQOLNH3&%V()6$RSLQLRQIURP1RYHPEHU
z ,QKHUHQWSODQWWR[LQVSUHVHQWLQIHHGPDWHULDOV
± +\GURF\DQLFDFLGOLQVHHGFDVVDYDPDQLRF
DOPRQG«
± )UHHJRVV\SROFRWWRQSURGXFWV
± 7KHREURPLQHFRFRDSURGXFWV
)XWXUHGLVFXVVLRQV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 72/75
8QGHVLUDEOHVXEVWDQFHV)HHG
z 7R[LFFRPSRXQGVSUHVHQWLQERWDQLFDOLPSXULWLHV ± 5LFLQ5LFLQXV&RPPXQLV
± WURSDQHDONDORLGVK\RVF\DPLQHDWURSLQHVFRSRODPLQH'DWXUDVWUDPRQLXP
±
S\UUROL]LGLQHDONDORLGV&URWDODULDVSS/ROLXPWHPXOHQWXP/ROLXPUHPRWXP
± JOXFRVLQRODWHVDOO\OLVRWKLRF\DQDWHV%UDVVLFDVSS&DPHOLQDVDWLYD
± +\GURF\DQLFDFLGDSULFRWVELWWHUDOPRQGXQKXVNHGEHHFK
PDVW-DWURSKDFXUFDV ± 6DSRQLFJO\FRVLGHV0DGKXFDORQJLIROLDXQKXVNHGEHHFKPDVW
)XWXUHGLVFXVVLRQV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 73/75
8QGHVLUDEOHVXEVWDQFHV)HHG
z 2UJDQRFKORULQHFRPSRXQGV ± FKORUGDQH''7KHSWDFKORUKH[DFKORUREHQ]HQH
z 2WKHUXQGHVLUDEOHVXEVWDQFHV
± 0HUFXU\QLWULWHV
)XWXUHGLVFXVVLRQV8QGHVLUDEOHVXEVWDQFHV
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 74/75
&DUU\RYHUFRFFLRGLVWDWVLQWRQRQWDUJHWIHHG
z FDUU\RYHURIFRFFLGLRVWDWVLQWRQRQWDUJHWIHHGV ± 8QDYRLGDEOHFDUU\RYHU±DVORZDVUHDVRQDEO\DQG
WHFKQLFDOO\DFKLHYDEOH
± ()6$RSLQLRQUHTXHVWHGWRDVVHVVULVNVIRUDQLPDOKHDOWK
DQGRUSXEOLFKHDOWK
± 3ULRULWLHVPRQHQVLQVRGLXPODVDORFLGVRGLXP
VDOLQRP\FLQVRGLXPQDUDVLQQLFDUED]LQDQGGLFOD]XULO
± 2WKHUUREHQLGLQHK\GURFKORULGHPDGXUDP\FLQ
DPPRQLXPVHPGXUDP\FLQVRGLXPKDORIXJLQRQH
K\GUREURPLGHGHFRTXLQDWH
7/28/2019 Frans Verstraete
http://slidepdf.com/reader/full/frans-verstraete 75/75
&RQFOXVLRQ
(8OHJDOIUDPHZRUNRQXQGHVLUDEOHVXEVWDQFHVLQIHHGLQSODFHVLQFHUHJXODUO\DPHQGHGDQGFRPSOHWHG
0DMRUFKDQJHLQE\HQWU\LQWRIRUFHRI'LUHFWLYH
(& 2QJRLQJUHYLHZXSGDWLQJDQGFRPSOHWLQJRISURYLVLRQV
RQXQGHVLUDEOHVXEVWDQFHV
,QWKHQHDUIXWXUHFRPSOHWHO\XSGDWHGSURYLVLRQVRQ
XQGHVLUDEOHVXEVWDQFHVLQIHHG±IXUWKHU
LPSURYHPHQWRIIHHGVDIHW\