The E100: Biotech ex­ecs are bull­ish about 2017, but fret about drug pric­ing and the FDA un­der Trump

About the End­points 100: This is our sec­ond biotech in­dus­try sur­vey, which we sent out to our in­vite-on­ly group of ex­ec­u­tives on Feb­ru­ary 6. 98 ex­ecs, pri­mar­i­ly in the US and Eu­rope, com­plet­ed the sur­vey, You can see a list of the en­tire group at the end of this ar­ti­cle.

The biotech in­dus­try is feel­ing bull­ish about its own prospects at the be­gin­ning of 2017, large­ly sat­is­fied with the fi­nan­cial sup­port that’s been flow­ing in to the field with most ex­ecs ready to hire through the year as the tem­po on deal-mak­ing re­mains up­beat.

But it’s not all com­ing up ros­es.

The in­dus­try is in a funk about the Trump ad­min­is­tra­tion af­ter a few weeks of head­lines over a trav­el ban con­tro­ver­sy and a rolling se­ries of out­spo­ken tweets, with a large seg­ment of these ex­ecs wor­ried that a new head of the FDA could come in ready to re­duce if not ac­tu­al­ly dis­card stan­dards on drug de­vel­op­ment.

And vir­tu­al­ly no mat­ter what Trump says or does, a clear ma­jor­i­ty add, we’ve en­tered a new era on drug pric­ing that will de­mand a new math on what ther­a­pies cost. As for the high-pro­file in­stances where com­pa­nies and CEOs have been fin­gered for price goug­ing, many be­lieve we’re see­ing an end game where the re­tal­i­a­tion is like­ly to be se­vere enough to stop such prac­tices for­ev­er.

That’s the bot­tom line from our lat­est End­points 100 sur­vey, which cap­tured the thoughts of a broad swathe of CEOs and top-lev­el ex­ecs in the in­dus­try.

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Down on Trump

Ful­ly two-thirds of these ex­ecs — out of 98 who re­spond­ed to our sur­vey — are deeply dis­en­chant­ed with Pres­i­dent Trump.

Thoughts ranged from “a smol­der­ing dump­ster fire with re­gards to health and hu­man safe­ty” to “his ac­tion on the im­mi­grant ban was mis­guid­ed. His in­abil­i­ty to re­frain from tweet­ing is ar­ro­gant. His ad­mi­ra­tion of Putin is fool­ish.”

A huge ma­jor­i­ty — 82% — dis­ap­proved of the pres­i­dent’s ac­tions. On­ly 4% found some­thing to ap­prove.

One of the pres­i­dent’s sig­na­ture ef­forts ear­ly on has been to blast what he calls out­ra­geous pric­ing for drugs. A big group — 63% — feel that the bio­phar­ma in­dus­try has en­tered a new era on drug pric­ing. But a strong ma­jor­i­ty of 56% be­lieve that al­low­ing Medicare to ne­go­ti­ate drug pric­ing, as Trump has said now re­peat­ed­ly, is the wrong move.

“I be­lieve that Phar­ma re­al­ly doesn’t get it,” said one ex­ec. “Ever since the fi­nan­cial cri­sis there has been a con­stant drum­beat by pa­tients, physi­cians, etc on the price of drugs. We need to be more fo­cused on bring­ing ‘val­ue for the mon­ey.’ There isn’t enough mon­ey in the world to ad­dress the world’s health­care. We need to raise the bar much high­er for our­selves and price re­spon­si­bly. We are killing the gold­en goose.”

“Trump told Phar­ma CEOs to get prices down, in­no­va­tion up and bring busi­ness­es back to the US. He means it and I be­lieve Phar­ma will self reg­u­late on bla­tant price in­creas­es (of which many are guilty).”

On­ly 24% felt that the sta­tus quo on pric­ing could be main­tained.

“Pay­ers are al­ready in­creas­ing pres­sure and there is ex­treme pres­sure in the EU. Ex­ces­sive price in­creas­es on gener­ic drugs must stop. Need to mod­er­ate price in­creas­es on drugs gen­er­al­ly to be more in line with in­fla­tion.”


Medicare price ne­go­ti­a­tions

There’s no doubt­ing the con­sid­er­able op­po­si­tion in the in­dus­try to push­ing Medicare in­to price ne­go­ti­a­tions. But a large mi­nor­i­ty, 44%, felt that there was good rea­son for Medicare price ne­go­ti­a­tions.

“Wrong move or right move, it’s an ob­vi­ous move. It’s the biggest pay­er and some­how, some way, this will hap­pen.”

None of the sol­id ma­jor­i­ty who op­posed see­ing Medicare lever­age low­er prices di­rect­ly ex­pressed their opin­ion on it.

Scott Got­tlieb

It’s ear­ly days in this ad­min­is­tra­tion, but sev­er­al of the ex­ecs who took this sur­vey ex­pect to see some fast changes out of Con­gress, some of which will like­ly spur the M&A side of the busi­ness.

“Ex­pect repa­tri­a­tion (of over­seas prof­its) which will dri­ve more col­lab­o­ra­tion/ac­qui­si­tion. Ex­pect volatil­i­ty in com­mu­ni­ca­tion from ad­min­is­tra­tion re­lat­ing to pric­ing, dri­ving con­tin­ued un­cer­tain­ty un­til ad­min­is­tra­tion clar­i­fies po­si­tion one way or an­oth­er on pric­ing.”

“The biggest im­pact they will have will be in the ap­point­ment of the HHS sec­re­tary and the head of the FDA (hope­ful­ly Scott Got­tlieb).”

“Wild­ly un­pre­dictable. Of the var­i­ous un­knowns now the no­tion that the FDA might con­vert ap­provals to “safe­ty on­ly” is the most alarm­ing.”


The FDA

There is a sig­nif­i­cant di­vi­sion of opin­ion about what the FDA should do un­der a new com­mis­sion­er. 43% said no sig­nif­i­cant changes are need­ed in terms of reg­u­la­tions, sat­is­fied that changes made over the last few years has sub­stan­tial­ly ben­e­fit­ed bio­phar­ma and stream­lined de­vel­op­ment with­out erod­ing stan­dards.

37%, though, are look­ing for sig­nif­i­cant changes.The theme, though, sug­gests the in­dus­try is look­ing for a con­tin­ued evo­lu­tion of the reg­u­la­to­ry land­scape, fa­vor­ing de­vel­op­ers but not gut­ting the gold stan­dard on ef­fi­ca­cy and safe­ty.
“Con­tin­ue to build on ac­cel­er­at­ed ap­proval frame­work.” 

“Do not low­er sci­en­tif­ic stan­dards; re­tain safe­ty and ef­fi­ca­cy hur­dle; in­crease use of sur­ro­gate and re­al world end­points, in­clud­ing da­ta from wear­able and dig­i­tal sources to help stream­line ap­proval with more dis­ease- and pa­tient-rel­e­vant end­points of ef­fi­ca­cy.”

“FDA has been do­ing a good job. We need to keep the high ef­fi­ca­cy stan­dard.”

“I ac­tu­al­ly think over­all the FDA is do­ing a great job, I don’t think rad­i­cal re­form is need­ed. But I do think that many of the ini­tia­tives and re­forms of re­cent years have been em­braced by Sr. man­age­ment, but not by the rest of the bu­reau­cra­cy yet.”

“Ter­ri­fy­ing to think of low­er­ing ef­fi­ca­cy stan­dards sig­nif­i­cant­ly. Not good for the pub­lic or the in­dus­try!”

“In many ar­eas, reg­u­la­to­ry sci­ence is decades be­hind ad­vances in new tech­nolo­gies and med­ical sci­ence. In the rare dis­eases, for in­stance, we need a rig­or­ous yet flex­i­ble reg­u­la­to­ry frame­work that does not ex­ist to­day. The fact that there is not even a re­view di­vi­sion at FDA ded­i­cat­ed to rare ge­net­ic dis­eases is a tragedy in it­self. “

“In­creased use of bio­mark­ers, ac­cel­er­at­ed ap­proval path­ways and per­haps even the in­tro­duc­tion of ‘con­di­tion­al’ ap­proval path­ways will dri­ve med­i­cines that are proven safe and ef­fec­tive to pa­tients as quick­ly as pos­si­ble. In fact, the most sig­nif­i­cant change that could be made at the FDA is to in­clude the pa­tient per­spec­tive at every step of the drug de­vel­op­ment and reg­u­la­to­ry re­view process. Do­ing so will save count­less lives.”
John F. Crow­ley Chair­man & CEO Am­i­cus Ther­a­peu­tics

Brent Saun­ders’ pledge

One change that got a broad thumbs up from the E100: Brent Saun­ders’ call for an in­dus­try pledge to keep an­nu­al price in­creas­es on drugs in the sin­gle dig­its, un­der 10%. A to­tal of 67% en­dorsed the move, with quite a few call­ing it sen­si­ble and vi­able or “a breathe of fresh air.”

But there was al­so a de­tectable air of skep­ti­cism that this kind of ap­proach could work as a longterm so­lu­tion, with many see­ing it as a log­i­cal tem­po­rary step.

“This seems clos­er to fol­low­ing the laws of grav­i­ty than a plan. But it should cre­ate some much-need­ed day­light btwn in­dus­try and (con­tro­ver­sial Tur­ing founder Mar­tin) Shkre­li”

“I found Brent’s procla­ma­tion a bit disin­gen­u­ous… He pro­claims he wilre­spon­si­ble on pric­ing but then takes 9.9% across his en­tire port­fo­lio. Re­al­ly! What in­dus­try gets 9.9% price in­creas­es?”

“I would say that we should em­pha­size ty­ing price in­creas­es to in­fla­tion in some way. If in­fla­tion goes to 15% you would not raise prices by 9% and if in­fla­tion is 1% you would raise less than 9%. I wor­ry about dog­mat­ic state­ments like “sin­gle” dig­it which do not take in­to ac­count the macro eco­nom­ic is­sues.”


The pulse on biotech prospects in 2017: Run­ning strong

This is the sec­ond sur­vey that is keep­ing the thumbs on the pulse of in­dus­try con­fi­dence, which is em­phat­i­cal­ly strong. On­ly 2% of the crowd are less than some­what con­fi­dence, with three out of four run­ning the gamut of con­fi­dent to ex­treme­ly con­fi­dence.

We have 57% rat­ing the flow of in­vest­ments from VCs as ‘good.’

“The cap­i­tal is there from spe­cial­ists for the right com­pa­nies.”

“If you have a great team and a good sto­ry, you can get fund­ed.”

But not every­one is hap­py about their ac­cess to cap­i­tal these days.

“I am con­tin­u­al­ly per­plexed by the de­sire to fund “the dream” ver­sus val­i­dat­ed, re­al drugs. I wish there was more in­ter­est in re­al biotech com­pa­nies that have rev­enues and de­liv­er strong cash flows.”

IPOs are off to a so-so start af­ter a weak 2016, so it’s not too sur­pris­ing to see ex­pec­ta­tions are lim­it­ed for the rest of the year. Forty-two per­cent ranked the IPO sec­tor as fair, with 27% fair, 17% good and 14% poor. No one thought it was ex­cel­lent.

About half thought that the IPO mar­ket will stay this way for the rest of the year, with the “bet­ter” and “worse” group split 29% to 19%.


Hir­ing

Close to 4 out of 5 of these ex­ecs work in or with com­pa­nies that are hir­ing in the first quar­ter, al­so re­flect­ing a strong up­beat tem­po in terms of ex­pand­ing em­ploy­ment, which we al­so saw last fall in our first sur­vey. 86% are hir­ing this year. No one plans to re­duce staff. The biggest prob­lem cit­ed: Find­ing the right peo­ple can be dif­fi­cult.

“We’ll hire ag­gres­sive­ly again this year.”

“Job mar­ket re­mains very hot. Lots of com­pe­ti­tion to ac­cess the best tal­ent.”

“We’re hir­ing ag­gres­sive­ly but good can­di­dates are hard to find,” says Yu­val Co­hen, CEO of Cor­bus Phar­ma­ceu­ti­cals.”


Biotech val­u­a­tions: Fair to good

The pace on deals and buy­outs has start­ed off with some siz­able num­bers in biotech, but our E100 ex­ecs weren’t feel­ing gid­dy about any of it.

57% of these ex­ecs found li­cens­ing deals were be­ing done for av­er­age amounts, 37% said they were high and on­ly 5% thought of them as low. There was a split on M&A, though, with 47% rank­ing val­u­a­tions at av­er­age and 43% call­ing them out as high. That cold be a sell­ers per­spec­tive, though, as Big Phar­ma buy­ers have been say­ing for sev­er­al years now that val­u­a­tions have been run­ning ex­treme­ly high, in their view.


So where do we go from here?

“Let’s keep our eye on the prize: mak­ing im­por­tant new ther­a­peu­tics that ad­dress hu­man needs. Let us em­brace val­ue-based pric­ing. Let us shun var­i­ous his­tor­i­cal in­dus­try prac­tice to un­rea­son­ably ex­tend patent mo­nop­oly. Let us aban­don un­jus­ti­fied year-over-year cost in­creas­es in the ab­sence of proven ad­di­tion­al pa­tient ben­e­fit or con­ve­nience.”

“A good year for biotech in 2017. Too many ex­cel­lent tech­nolo­gies and in­no­va­tion . They all will find homes!”

We end with an anony­mous com­pli­ment:

“Well done, John and col­leagues. End­points is a re­fresh­ing new source for biotech- and phar­ma-re­lat­ed news and views.”

It was just 1 out of 98, but we see a trend de­vel­op­ing.

Do you have an idea for our next sur­vey? Drop me a line at john@end­pointsnews.com

  • Here’s a list of all par­tic­i­pat­ing End­points 100 ex­ec­u­tives
    Jef­frey Al­bers Blue­print Med­i­cines
    Alan Auer­bach Puma
    Stephane Ban­cel Mod­er­na
    Chuck Baum Mi­rati Ther­a­peu­tics
    John Bea­dle PsiOxus
    Kees Been Lyso­so­mal Ther­a­peu­tics
    Arie Bellde­grun Kite Phar­ma
    Nes­san Berming­ham In­tel­lia Ther­a­puet­ics
    Jean-Jacques Bi­en­aimé Bio­Marin Phar­ma­ceu­ti­cal
    Kate Bing­ham SV Life Sci­ences
    Detlev Bin­iszkiewicz Sur­face On­col­o­gy
    Kevin Bit­ter­man Po­laris Part­ners
    Robert Blum Cy­to­ki­net­ics, Inc.
    Bruce Booth At­las Ven­ture
    Ed­uar­do Bra­vo Tigenix, SAU
    Wern­er Cautreels Se­lec­ta
    Chip Clark Geno­cea Bio­sciences
    Robert Cof­fin Replimune
    Ron Co­hen Acor­da
    Yu­val Co­hen Cor­bus Phar­ma
    Robert Con­nel­ly Ax­cel­la (Pronu­tria)
    Bernard Coulie Pli­ant Ther­a­peu­tics
    John Crow­ley Am­i­cus
    David de Graaf Syn­tim­mune
    Kim Drap­kin Jounce Ther­a­peu­tics
    Cameron Dur­rant Kalo­Bios
    Glyn Ed­wards Sum­mit Ther­a­peu­tics plc
    Eliot Forster Im­muno­core
    Tas­sos Gi­anakakos MyoKar­dia
    David Giljo­hann Ex­i­cure
    Robert Gould Ful­crum Ther­a­peu­tics
    Max­ine Gowen Treve­na
    Mike Grey Am­plyx
    Geral­dine Hamil­ton Em­u­late
    John Hau­rum F-star
    Rachel Hau­r­witz Cari­bou
    Pe­ter Hecht Iron­wood
    Mary Lynne Hed­ley Tesaro
    Olav Helle­bø ReNeu­ron Group plc
    Rus­sell Hern­don Hy­dra Bio­sciences
    Rich Hey­man Hey­man Biotech
    Na­tal­ie Holles Au­dentes Ther­a­peu­tics, Inc.
    Steve Holtz­man Deci­bel Ther­a­peu­tics
    Hervé Hop­penot In­cyte
    An­nal­isa Jenk­ins Di­men­sion Ther­a­peu­tics
    Jeff Jonker NGM Bio
    Kevin Ju­dice DiCE Mol­e­cules
    Rachel King Gly­comimet­ics
    Gene Kin­ney Prothena
    Art Krieg Check­mate Phar­ma­ceu­ti­cals
    Je­re­my Levin Ovid Ther­a­peu­tics
    Howard Liang BeiGene
    Jay Lichter Aval­on Ven­tures
    John Maraganore Al­ny­lam
    Alex­ey Mar­golin Al­lena Phar­ma­ceu­ti­cals
    Tim Mayleben Es­pe­ri­on
    Sean Mc­Carthy Cy­tomX Ther­a­peu­tics
    David Mott NEA
    Lon­nie Moul­der Tesaro
    Glenn Ned­win Sec­ond Genome
    Don Nichol­son Nim­bus Ther­a­peu­tics
    Hugh O’Dowd Neon Ther­a­peu­tics
    Bernat Olle Vedan­ta
    Rick Orr Ad­ynxx
    Ju­lia Owens Mil­len­do
    An­toine Pa­piernik Sofinno­va
    Pier­lui­gi Parac­chi GENEN­TA Sci­ence
    Alexan­der Pas­teur F-Prime Cap­i­tal Part­ners
    Joe Payne Arc­turus Ther­a­peu­tics
    Michael Pelli­ni Foun­da­tion Med­i­cine
    An­drea Pfeifer AC Im­mune
    An­drew Phillips C4 Ther­a­peu­tics
    Richard Pops Alk­er­mes
    An­na Pro­topa­pas Mer­sana Ther­a­peu­tics
    Lau­rence Reid Warp Dri­ve Bio
    Nor­bert Riedel Aptinyx
    Adam Rosen­berg Rodin Ther­a­peu­tics
    Gregg San­do Cell Med­ica
    David Schenkein Agios
    Denise Scots-Knight Mereo Bio­phar­ma
    Paul Sekhri Lyc­era Corp.
    Tito Ser­afi­ni Atre­ca
    Ar­mon Sharei SQZ Ther­a­peu­tics
    Lau­ra Shawver Cleave Bio
    Clay Sie­gall Seat­tle Ge­net­ics
    Nan­cy Si­mon­ian Sy­ros Phar­ma­ceu­ti­cals
    Harpreet Singh Im­mat­ics US
    Sander Slootweg For­bion Cap­i­tal Part­ners
    Jeff Stein Cidara
    Carmine Sten­gone Ave­las Bio­sciences, Inc.
    Niclas Stiern­holm Tril­li­um Ther­a­peu­tics
    Clif­ford Stocks On­coRe­sponse
    Hamza Suria Anap­tys­Bio
    Mary Szela Aege­ri­on Phar­ma­ceu­ti­cals
    Nan­cy Thorn­ber­ry Kally­ope
    Praveen Tipir­neni Mor­phic Ther­a­peu­tic
    He­len Tor­ley Halozyme
    Dou­glas Tre­co Ra Phar­ma­ceu­ti­cals
    Steve Tre­gay For­ma Ther­a­peu­tics
    Tim Van Hauw­er­meiren Ar­genx
    Mark Vel­le­ca G1 Ther­a­peu­tics
    Greg Ver­dine Fog Phar­ma
    George Vla­suk Nav­i­tor Phar­ma­ceu­ti­cals, Inc.
    Robert Ward Ra­dius
    Ryan Watts De­nali
    Mal­colm Weir Hep­tares
    Mar­tin Welschof Op­sona Ther­a­peu­tics Ltd
    Doug Williams Co­di­ak
    Troy Wil­son Ku­ra On­col­o­gy
    Steve Yang WuXi AppTec
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