IONS - Earnings call transcript Q2 2018 | Ionis Pharmaceuticals, Inc.

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Operator

Good morning and welcome to the Ionis Pharmaceuticals Second Quarter 2018 Financial Results Conference Call.

As a reminder, this call is being recorded. At this time, I would like to turn the conference over to Wade Walke, Vice President of Investor Relations to lead off the call. Sir, you may begin.

Wade Walke

Thank you, Cole.

including encourage Ionis go the financial Web and financial I section the press measures begin, the related the of discuss of site tables, that we we everyone pro today. to to investor release GAAP will Before to reconciliation forma a to find we results business. We financial the of our better believe pro our manage economics represent forma business and how

President Akcea Stan accompany your Crooke, statements. I posted Boyce, would slides Sarah of contains to Hougen, today's on Monia, Officer; Officer. our Damien draw to that discussion which also of site language on attention Beth today. have and Chief and We Operating forward-looking call Board Web Officer; like are Chairman the Business Officer; Chief slide Brett me With our Chief Executive McDevitt, three, Financial Chief Therapeutics; our

forward-looking results filings based beliefs. risks We which details. discussed actual our These will Stan. SEC materially. the the in to risk to the And are factors additional consult our and and subject call statements statements, be I'll to certain turn I encourage that, may current over and expectations with you for making are differ uncertainties, on

Stan Crooke

Thanks and stronger second-half with a of the for Thanks, welcome we first-half even an pro and expect $X us. and good forma the Wade, million strong We ended morning the joining position everyone. in financial operating income, year.

year operating of on TEGSEDI in forma WAYLIVRA. and of third are do deliver while pro and our that investing launch We the track to we profitability, even

HTTrx prime with progress the and EU a favor regulatory designation approval interactions in positive the We head received are the Ionis comp of received to pleased agencies well. continue in that our IONIS-HTTRx this and in WAYLIVRA pivotal Roche, paved accelerated Huntington's of partner, study a like an could remains drug And SPINRAZA. European believe shortly. for way another track on initiate transformational the to drug, be We disease. most approval

hATTR amyloidosis, patients IONIS RNA-targeted company. TEGSEDI, multi-product the sustainably profitable therapeutic is the of approved a first approval now with for With

transformational in be medicines adding shareholder PTC Biogen the revenues around royalties SPINRAZA's driven to Looking expect and from will continue we and Therapeutics. accelerating while use forward, short-term, patients TEGSEDI to and earnings In to challenge product sales delivering revenue expands growth or by increased increasing world, and of the and by U.S. and SPINRAZA, the from earnings meet the the Latin access into two these as with America WAYLIVRA, broadens expanding drugs of value.

Today, As that wave in portfolio revenue next have trials XX shared, we may enter on drugs fuel These three enter benefit than of drugs the patients more additional pivotal in growth earnings and the to a the we'll of near-term. we opportunities, with our previously the and trials potential believe represent focus may substantial drugs we commercial mid-term. shortly. pivotal of that

deliver these bring remains shareholders as ever to increase of plan to substantial continue drugs commercial value. important And while result, their we'll same goal. as long-term progress to illnesses. to at more we to the made patients serious accomplishing Our this patients, the toward believe and value life-changing time we address a medicines capturing We've

first-hand. Officer, had industry, and guidance call Before development our us advance his over of work we past, over as corporate the value to activities pipeline has the broadly leadership maximize to him experience in drugs. opportunity to Ionis' Ionis lead Damien McDevitt, throughout commercial team, the continue the closely and seeing years pharmaceutical Damien years we the with the of company with I I provide would XX our the skills in Chief member who newest turn like of to as introduce executive Business and will June. strategic Beth, joined Damien in

to say Damien join like Damien, would welcoming in few you to team. So And me our words? please a

Damien McDevitt

with pipeline. here clinical near-term a our be drugs broad It's the time a and as of great Akcea, we to with patients milestones, on affiliate, transformational team. that Stan. join multiple expansion of great includes applying deliver execute value It's our continued agenda to need. goals two commercial our launch in my the to delivering shareholder help the to Thanks, I while to experience business medicines across look to forward

Now, I'll over to call turn the Beth.

Beth Hougen

Thank million, ended and of with of income both of forma first-half to We on attributable income you, Damien. a Ionis' $XX XXXX the net million, shareholders operating pro $X basis.

in driven including more to compared were first-half increase results a from Our than SPINRAZA. the a of strong commercial increase revenues revenue XXXX, by three-fold XX% in

revenue even revenue become and greater commercial an second-half in total grow year. add lead SPINRAZA in growing R&D expect increased revenue. revenues We TEGSEDI product sales increases commercial our portion will we income revenue to the operating of We to as both this of to and anticipate WAYLIVRA and

royalty this increase Looking to global increase, into higher royalties forward second-half to we as the tiers. and of move continue projecting SPINRAZA the year, are we as sales to

potentially to from this year. and We revenues WAYLIVRA product also add TEGSEDI expect

With amortization opportunities this the addition from the numerous R&D we our second-half year. base expanded our payments, Biogen substantial and full collaboration revenue of of our project of also to of two milestone in quarters to increase

meet SG&A of basis. on to range $XXX million expect to in guidance. expenses operating our in forma million, We're million, We the a of range expenses $XXX R&D to both and million expense $XXX $XXX projecting pro the

track seven years. us cash, invest our the approximately ended billion with operating on in to with forma year of first-half out end last consecutive for two project accretive we the are cash, drugs. six of third commercializing pro the we than in to We $X billion making of cash $X.X continuing XXXX Importantly, in year while new and income, achieve more to

from each and R&D earn ways; and revenue, balance products of with pipeline, to call commercial drugs maximum collaborations our growing Our our for partners account our a substantial retain we which revenue. commercial in of our pipeline drugs. expand call through and revenue sales we build cash our increases We advance our ability for two value which own commercial of the we

product first-half from increased first-half which commercial revenue to now approximately XX% in the $XX on our in of patients X,XXX was revenue the result with and revenue this a number represent to increased today quarter passive more and and R&D the from to patient on In large as receiving of SPINRAZA continued including XX% SMA patients royalty strong Asia of source in particularly Europe, year. increased than XXXX growth million XXXX. Adult million growth. commercial but outside quarter. XXX% for for saw $XXX sales for very revenue EAP nearly SPINRAZA of of SPINRAZA, first America. was this of Biogen approximately as Latin a are we SPINRAZA, sales but SPINRAZA Biogen expect number Biogen expects the patients to growing over our are And increase. a prevalent Worldwide population of the population from of to the continue only globally reimbursement first a to adult these of profit The increase revenues global compared by U.S. the SPINRAZA meaningful saw Pacific million. second Our continue increase patients access a be year. XX% all for group patient The clinical the patients underserved significant represents today performance XX% to patients and accounting SPINRAZA, U.S. primary from opportunity commercial our $XXX studies. quarter the the which is this are in

also anticipate and potential in WAYLIVRA. revenue growth TEGSEDI We commercial from

ramp WAYLIVRA sales disease up. product has generate drugs Importantly to TEGSEDI sales rare and with other operating as potential significant from a margins consistent

of comprised is revenue four R&D Our key components.

we've received first The is years. We the component the partners upfront from over several of upfront payments. amortization typically payments amortize

revenue expect component We result Biogen the grow of this XXXX to a second-half our as in expanded collaboration. our of R&D of

million Biogen next over payment from will upfront We of the XX $XXX the years. recognize

years. estimate in approximately to year. year a in $XX new will will we million future our with upfront from we in Beginning million potential we per amortization grow be $XX forward, In and collaboration $XXX this this estimate the million this the we Specifically, XXXX payments recognize majority second-half total, of recognize vast will with year. year this of

revenue the while for Typically events our partner. component milestone we or our -- two services achieve second R&D in a our when payment in of The key payments we we is our the performing partners milestone are collaborations.

the over services. amortize we of are performing period into will those time the We payment revenue

For when we quarter Biogen payment the of conducting our the started not the third next milestone $XX as million in partners XXXX, and from study the I, we example, revenue. years. are milestone we for are study, we immediately million in amortizing II from payments received payment we recognize Phase a are over Since the we we $XX When the three payment services, IONIS-MAPTRx. received

not we achieved. last performing for year. entire milestone For million collaboration; the milestone collaboration $XX example, in approved payment we when was were $XX a Europe under SPINRAZA SPINRAZA Biogen because was it But payment from we Biogen received services million recognized our

our the we component that provide of drug have The through the as R&D large is we the drugs. we received are payments our value with created have reflect License our licenses exclusive third fees to partners we when advanced development. license revenue typically fees

revenue our R&D services the a quarter growth of partners XX and source recurring for this TEGSEDI clinical from of is revenues XXXX, to SPINRAZA than us, And to Sarah and XXXX, an million the to a after and fall update. few we revenue quarters. expected have WAYLIVRA earnings conduct around model. partners. fees commercial million supplies average with forward a R&D With not including per R&D averaging in because exercises As to pipeline the call become revenue commercial Already various which to the that, million year, AKCEA-APOCIII-LRx fee. license collaboration license from to from Akcea. this to Last, either years, we option have matures, earn $XX license our for that more under PTC we drive have $XXX of our consistent for source transaction. directly revenues valuation XXXX, license R&D provide we sustainable each beyond. our our revenue anticipate these has the on AstraZeneca. growing our looking manufacturing second important fourfold a as from our R&D $XX we revenue and sales commercial earned we fees its XXXX In turn from fee. and of sustainable more than AKCEA-APO(a)-LRx license as and licensing to Novartis over had will annually that Since generally million bottom we to product this summary, In note line increase. over why I'll its half and increased the and revenue It's will include together work earning In should drugs second-half of we expect to revenue last $XXX growing provide do recognize of of with revenue in last we from has our component

Sarah Boyce

measures launch have The details you, Thank TEGSEDI for of the symptoms the of to is their entire team Together benefits of stage include to The neuropathy. last WAYLIVRA. to product Beth. now II we first The life community, TEGSEDI families who neuropathy. it patient finalizing I label is the with in of is launch drug European EU. And approved hATTR It launch. now excited begin quality the important Germany. and both event. hATTR for in Akcea and by first ready both disease. broad this stage in approved team The patients be and and for TEGSEDI patients is show approved are will the and is with hATTR

the post-summer quickly launch we geographies in we team place pricing typical The will in as set Germany. sequence these fully to to follow for continues across Our when Germany TEGSEDI announce the teams as launch ready launch. launch and And a for have possible. plan that We in in Europe. ensure is EU EU

Akcea, rarity and patients. bring and and that For the the both to diseases these to both we WAYLIVRA, TEGSEDI the burden reflect drugs to price the of value expect of hATTR

upper are the per We typically to price disease XXXX these $XXX,XXX in report, year. We changing range rare approved to similarly our rare plan published that and article be to According drugs. it to the priced disease $XXX to in expectation range. within the expect responsibly, a of a of not drugs drugs disease rare in to end price U.S. other life

monitoring basis for program be We possible to while market consistent patient staying will each and to rollout support straightforward physicians, the standards country as according a philosophy services for which our our patients, by with country the on caregivers. will simple local is make and support in as

after access access We team review country. the of as to are the investing are quickly to to ready And FDA the with patients and as support interactions U.S. market possible. on level patient allowed physician as is are TEGSEDI in in that U.S., diligently leading have highest date. these continuing markets the PDUFA as In track. October and remains provide The we positive our possible working to in And is launch to X Canada we of up our in each approval. soon

fully team case Our is and U.S. market medical, built sales, including TEGSEDI access. managers field

see to in in identification disease and and well team's effort progress focused education both growing our as our continue patient website. sale interest our focused physician We as Course patient hATTR the Change website strong from hATTR Guide the stage

panel supportive resulting over recently diseases neuropathy in program and U.S. testing genetic program hATTR. of rapid genetic confidential counseling testing confidential genetic in the a potential HATTR people and This counselling. with offers In hATTR by and Compass Compass we combined genetic is suspected addition, XX launched genetic with doing for results Canada. a

WAYLIVRA Turning XX. date PDUFA a August of a to WAYLIVRA, reminder has as

continues our continue program review we for we're level with second-half approval key Health interest enrol on opinion in these early drug programs patients process of to our physicians. and on and Europe, Canada late from in each of study an Our Emab In increasing seeing with WAYLIVRA. WAYLIVRA, and XXXX. we patients access PHA The anticipate

Brazil for particular living We market have markets drugs plan which and significant into TEGSEDI our a and people PTC partnership with large TEGSEDI, with We through for drugs with plans these accelerate significant for to access Latin a global a also market our of is with population and expansion to now in expand WAYLIVRA accelerated America hATTR. represents opportunity Therapeutics. both new

KOLs, and Brazil the late WAYLIVRA. a of neuro rare has we One market physician a to record and and this in the patient enrollers partner and team making the for of PTC year. our proven Brazil PTC including have Latin them success the disease in is right top TTR study identification, track obtaining support established plans filings with in and in expedite program great patient education TEGSEDI access America from

WAYLIVRA We approval. and upon are well positioned to TEGSEDI launch

Brett from the are HATGR over people We bring to for These I pipeline. and excited now low doses. to the to made turn progress about benefit. with drugs review And highlights and Ionis may we have key

Brett Monia

Sarah. Thanks,

We in pipeline needs. continue progress value to areas of make our first high unmet on the half of XXXX high excellent therapies focused in with delivering

when interactions endpoints New study of highlights Some patients medical Both treatment early Phase of significant the of with and highlighted granted as to question, to the publication publication TEGSEDI was regulatory and in designation prime compared Ionis endpoints. TTR in Union. with disease. in with Medicine, England timelines placebo prestigious it this such this Roche modifying disease co-primary doses important, course the with youngest highlights the a TEGSEDI streamlines of faster drug TEGSEDI of and include potentially quality Journal community. our of designation of also highly by the to sustained the importance seven in of people can publication review help progression being the bring HTTRx known measure journal polyneuropathy Prime partner EMA of medical Huntington's and European disease benefit NEURO-TTR life market with because the X with in is both RGXXXX accelerates the neuropathic seen in which

all Map of was in the temporal our designation in is Biogen our this and programs. these target is Disease with substantial highlight people low four in with of completed TRx or currently the studies consistent programs. we EU programs, In study drug across we for Dementia safety diseases new treatment with clinical TRx Alzheimer's with Ionis of very like is Another granted profiles reduction X and each frontal the was which excellent orphan drug program, patients partnered like with and in FTD, Phase demonstrated

look upcoming events let's the at now some in So pipeline.

focus we have starting advance the We advanced near-term we of them, excited stage have that in of about drugs want and and studies will disease. today the into two Huntington's studies all to XX drugs with we potential pivotal and expect two three remain shortly on late

Huntington's have this in Huntingon is achievement clinical in along drug's of and pivotal We soon, to of to only slow or disease this lowering demonstrate start designation. drug a potential study protein, trends and the the to also with always patients. drug to support this these progression we halt patients in this These substantially disease HTTRx Ionis plan reported first results large prime part these were benefit results devastating programs of with perhaps in today's

with XX% risk is in like levels to it's high to levels. is Lp(a) Cardiovascular treat approximately becoming factor currently determined recognized Elevated cardiovascular Lp(a) Phase exceeds population to of they disease. in increasingly the in plan high drug patients advance as Lp(a) and a contributor it's with options genetically X drug cardiovascular licenses the patients Novartis's and treatment in target no disease. sufficiently available major Lp(a) the world-wide present specifically There Assuming

translate start Akcea program studies TTR-amyloidosis the X be Phase to and version on the wild Akcea before potential importunacy which we doses to Lafora of data expect anticipated We're our into including We people clinical enter this for targeting results Another with well will start from type cardiomyopathy. both end other TTR-Lrx advancing pivotal or is we even frequently. Based its monthly year with to believe Akcea's rapidly. planned mentioned which is XXXX. LICA TTR-LICA hereditary less and attractive with TEGSEDI LICA a in very pre-clinical TTR-amyloidosis option of due studies will

the as and infectious a cardiovascular we've advancing our disease of oph-thalmic NASH near-term LICA disease, As areas diverse In diseases. in this disease, range in disease, building made program. mentioned excellent pursuing progress rare we're

our in cardiac importunacy large for profiles, with plans In study outside and consistently great In cardiovascular dosing like LICA milestone those XX amyloidosis clinical patients doses drugs to a receiving monthly months safety our tolerability our substantial report generation few or pipeline. as TTR. to frequent that enables drug suitable Phase for Akcea such doses represents XXX months with increases with Our and monthly weekly with patient X lower the elevated less of is population Akcea and a and TTR-Lrx due study drugs. LICA longest patients as those Studies demonstrate to in in disease LICA LICA two key approximately technology in non-LICA or much Lp(a) the six over today the data largest

with to our at Now, of attention medical disease drug bring in of which Ionis development in disease We're large reinforcing eight a rapid HTTRx in X SAG let's for to into we've expected partnership disease year. drugs neurological IONISXlRx related next Data as Phase diseases our Biogen, of with pipeline. XX a patients neurological each this for program substantial leadership diseases the in currently area. is diseases study unmet excess pace needs, benefit a continues new turn advanced at modifying early Neuro Ionis in discovery SAG study, number total Phase an Neurological discovered advancing you our in X including broad potentially medicines XX if range In Alzheimer's which ALS. for and a Inois from patients. position

drug Beyond in clinical drugs more have in these research stage and more programs and than we discovery. XX late three drugs trials

our recently under two advance and Akcea follow-on, We programs development these Alzheimer's include in We build currently year. disease, expected additional neurological also to continue a disease five development it's in into pipeline drugs program programs like a TEGSEDI parallel. diseases for next Ionis including neurological owned rare which enter have to own for

XX we XX addition, the to program is a more owned to that placed over add months. next In Ionis expect several

So early XXXX catalyst half with for second preparing a in and we're XXXX.

and head disease we're clinical cancer. of related additional expected technology. near sharing to which with forward TEGSEDI X most look with the Day X include clinical with hosting on in approvals and levels join initiation in turn a important data as starts provide data with advance and cardiovascular from at in. Sarah advances Phase Phase pipeline presentation WAYLIVRA. MD X are over you high we're many more back event results patients it our trial data ALS We with in these study Anderson New on Investor and we SAG be discuss including the in-depth our X(X) our from including And business Clinical the panelist studies. exciting this will expecting important can in As pivotal in At key year term hope I'll upcoming particular AKCEA-APOCIII-LRx We and patients from of From Lp(a) launches our November Phase York. making Stan. the with will we progresses neck Friday and our mentioned you X patients in and that,

Stan Crooke

TEGSEDI EC's with proof Thanks, of the EU decision, first on for now of Brett. targeted amyloidosis. a with is The an approval course world's the event in is TEGSEDI patients important ATTR therapeutic

delivering progressive with suffering better the in to with a future. Ionis TEGSEDI, systemic vital profitable patients. the disease medicines Now, is approval of have sustainably for And transformational multi-product patients hope company now

to launch approval is in as possible the in upon approval as to and EU in Looking to and ahead, and treat we is a years in believe quickly substantial of ready to the after ready the U.S., the growth we're Akcea launch second-half in pipeline patients positioned EU. after WAYLIVRA year this the in Akcea of growing come. also in products approval U.S. quickly the need, for With TEGSEDI

is the We the design accelerating commercial maximize And And expect with value. commercialization is and commercial of our drugs, to to that potential an in PTC you maximize important the Cole? us the that, for in flexibility call real Q&A, transaction with deliver Can to step going up this for strategies that profitable, participation for with the we're value, Q&A. each turn over near-term. in set I'll our and

Operator

Certainly.

from question ahead. & Please first We comes Chad Needham from the session. Instructions] And go Company. [Operator will begin Messer now our question-and-answer

Chad Messer

Good A deal may, more on with taking Great, I one. morning, thanks general your then my and and a one PTC, question. for specific if thanks. couple, a

the process one, with of certainly my can thoughts the And versus Seems Latin your you wondering own? would the that [indiscernible] force then Latin to the if sort general possibility of the have used other ground PTC own building thinking yet with or with starting to on partner go you I America your with of answer been as -- on have decided that So walk a Akcea. thought for sort And at guess talent can you us you through you America, in Thanks. two you need and post to on comment which you kind do aren't could of whether might is how the more question of be more specifically, of launch my geographies size expand covered. they your drugs? if

Stan Crooke

Thanks, Sarah the and then first Chad. on answer that, you'll take question. I'll second one, if then Sarah, can and amplify the

later. I the full the made U.S. the progress, would includes Akcea the think little America, it course, ourselves, but if a team. launch our to that. for great we drugs. for have very possible rapidly as we fact time are our logic collaboration for EU for a a we We've doing with With to we in and hands Latin be do PTC prepare And it's [indiscernible] that, were both it of certainly as the moving

So PTC big of transaction in TEGSEDI us sales [indiscernible] that have PTC. not the provides for both accelerate or to a products. think America and included Latin WAYLIVRA. that's we win a for in And the We form remember great opportunity

exactly these did And I what And the we've PTC build force plenty of America transaction. that I we than Chad, opportunity just the we our launched Europe. we the U.S. successfully said and so have wouldn't that fact read any into in after believe Latin more drugs to

these fully a made And function to territory ready as basis. will on territories in advantage take other The of we other full opportunity be markets. of the are a how

Sarah Boyce

And have successful fully in in up America, a extremely size Latin have Chad, just your in around the add, there. been organization They particular in in commercialization America, in and to built to they PTC Latin actually question Brazil.

for quickly One rapid with they already as around TEGSEDI key are and of was both that WAYLIVRA, WAYLIVRA time partnering significant Stan to that acceleration PTC and opportunities. possible it is, as allowing and place. have they drivers, to in Certainly provide as infrastructure because the TEGSEDI said, patients

the in the So, drive first attitude Latin already to great people thrilled around the we're are And of patient to of we chemistry, America organization, and needed similar really success very the have some to met; infrastructure, we focus. are with sense and that really expect expansion but that had PTC's leadership, urgency people and that place.

Stan Crooke

Thanks, Sarah.

question, please. Next

Operator

And question Buren our Jaffray. with go Piper next Van Tyler Please comes from ahead.

Tyler Van Buren

taking questions. to the of I course, would Thanks label afternoon. good first discussions guess question without have the with have, any be giving for begun? Hi, specifics the WAYLIVRA

Stan Crooke

along would we're say regulatory think maximum with FDA. process that to Well, well the I today. the appropriate And in be the that's

Tyler Van Buren

who TEGSEDI at Great, symptoms reach who and on you that's cardiomyopathy the TEGSEDI that, should guess the with early to have are launch? respect to patients how of the look cardiologists just for the up polyneuropathy, do looking WAYLIVRA specifically And expect to then those what patients I I respect following And with metrics guess helpful. to launches, we success? commercial at determine

Sarah Boyce

the first, cardiologists. with starting back So, part with

engaged as calling from identification. and is and team hematologists neurologists, well field cardiologists a patient Our disease as on education perspective already and some

with the also in we're that's partnership broad of have of and physicians, for the clearly have that things they absolutely that the also close were who There is One to cardiomyopathy on one very cardiologists, we that patients. many label and had and of will polyneuropathy, Europe, be achieve. by, symptoms had discussions neurology, cardiology working of we quite also found covered between in able example things particular the be They these in patients closely. to would our need a and

won't the so on when one drugs you fully We're our of IMS -- going system is the things so through distribution report down of that terms launch in In using place. metrics, tracking a route. that typically pharmacy, specialty

such metrics be from we conversion well reimbursed as at, as over all forms, then as to and start we'll times form we as at identification, us, like patient looking looking look at For things start have a drug. patient

that of at at. the you metrics types but we're looking as things the guidance give around and that'll And orphan flush that that, closer So of out be get in typical we'll types space. we more that the look launch to

Stan Crooke

the that handle together their services think that Akcea or both system. and that practitioners in will and they retention. get medicine, take do teams patient really And these excellent Paula, process I be the think Sarah. so Sarah, Thanks, patients, helping and helpful helping through remarkable put And we I all at it. also contribute a will then getting patient service can to have patients, identifying substantially think them certainly system paperwork care them handling of And everything the

those Ionis the we'll be so very here and all at systems looking And carefully at Akcea. of performance

Tyler Van Buren

confusing get the of Great. the want is of And out think the lack efficacy, the well upon it that despite your terms some in that based in a being fact the benefit [indiscernible] patients among they'll just their to if done it long-term? abroad to benefits over options near-term what month. for of a one kind mortality maybe expectations given in updated you mortality which of last other data potentially There's they to end use do question, KOLs guys wild-type available, regardless so to of I the at talk just perhaps segment and hasn't carve be able need show the own

Brett Monia

This Monia. this. take me let Brett Tyler, is Sure,

cardiac approved is X III increase bit top been a U.S. jurisdictions a report the did significant polyneuropathy did Phase significant it data they They to in So, of population as outcome. has not of had has for you dose struggle in stage with some line -- as families reaching course. in and said the the study which

there So expecting, well mortality not benefit intact what significance or is or presented Whether the in response. they we they hospitalizations way as whether or will on and whether type. significant know will population, whether that versus a they not vegetarians have as the both dose be populations are wild same don't we ESC, not when

this there so don't that's and type learn So will the today. later is we treatment about we is more no month know wild you type much population for wild about. for this asked There other

that better a like population. add, will So wild-type with just only our data study go we that's study believe patients the we've that design the III be bar develop we you high, LICA if will expected, to in do very mechanism cardiomyopathy look isn't Phase our and is the Sarah, and significance will superior gone from learn like mechanism, for design deal we so with We and there. show for us is whatever we their we to and treated they Stan? as our, something our help from at want we

Stan Crooke

Just the one potentially after thing we be will trouble also the course, that the are getting but by causes the the add stabilizer. of think complimentary, a with mechanisms two to protein benefit protein from could remaining benefit great brought

easily treated that could we both drugs. very So might patients with imagine be

Sarah Boyce

answered. that think I

Tyler Van Buren

Thanks. you Thank much. very

Stan Crooke

for Thanks thought. the

Operator

Wells Fargo question next our from And go Please from Securities. Birchenough Jim ahead. comes

Jim Birchenough

sustainability? contributors congrats of first of about terms revenue progress continued that the R&D and grow guys does the science you first-half this couple all How visibility line in growth four when line products, year questions year. Hi, the the go the the far the some of a revenue next several of feeding the from line, contributors during think think and years. to you is over about the on on or A I when should revenue next that on me those just what's

Beth Hougen

Hi, Jim Beth. its

it each as get grow the about the of will and to to seven as last continues the and continues has The think pipeline the grows years to it and process pipeline grow, in will continue that mature drugs it will revenue we later elements that I those to one substantially, believe it done in increase So grow. the the six, has market. to grow so -- that development R&D reach continue we spoke and those as potential

we that growth trajectory. and of see significant out sustainable So being very

Stan Crooke

that add a of very also commercial affiliates. through drugs judiciously after think we But partner to large And proof today. built and ourselves that to commercialization of much a of those are drugs commercial APO(a)-LRx really sizable Jim both just very require concept everyone and intend pipeline a infrastructure we we and fraction with those for we have we that APOCIII-LRx greater and remind even to revenues development commercialize like to retaining

the for large potential require for that increased drugs in that our really So company are drugs kinds of for combination both number from adding available of that partnering. those partnering strong continued -- partners we those believe and unavailable resources, the of pipeline are interest

future that foreseeable types those all As grows, of and our that grow certainly of that of assures the plan. value drugs technology for continue the the a those to will revenue fact, that's

Jim Birchenough

these do high And then, both revenue maybe Orphan expectation, next highlighted margin expect of those year Stan a you next own on your profitable be Drugs, you nature driver TEGSEDI and as of net drugs profit WAYLIVRA, the off to is well? this year

Beth Hougen

Beth, watching actually time, contributors And expect will but for drugs this us launched are watches. certainly subsequent believe to is think substantial our be early I then, we we the drugs too be and before in earnings. appropriate could Jim, be it's So the saying

Stan Crooke

are XX, best-in-class even through we and sustainably are grow. profits first-in-class Akcea what that is are consolidated remain of pipeline proud to the and we of a those we we profitable remember drugs two advancing and think drugs all so launching expenses I really going novel or

focus to quite So business attention attractive I a is and I important and and think think be model. the for in I do on the would bit the that's acquisition the investor's of really us technology which thing that product position

Jim Birchenough

one last TTR but on opportunity quickly NEURO-TTR could a sufficient follow-on think wild-type faster one a an opportunity focus the strategy Brett TEGSEDI obviously reduction in to just And the as be on perhaps into might is expand for in the there that on get cardiomyopathy and market TTR you do patients? that LICA alone population to market population for and LICA the

Brett Monia

to happy take Jim, sure Yes, that.

that towards with both wild-type LICA start you are our are for clinical first we as as then, patient a study, the development next be you hereditary We studies neuropathy study TTR know, specifically will patient a that TTR be we population if to a label year well the the rapid -- we both. track year. starts TEGSEDI as strategy that clinical believe working So will this really there. expect And cardiomyopathy indications population pursuing path to these LICA fast for get the label with will for to -- fast going

that track still be Phase study only mechanism learnings something with look wild-type The do there. get patient that TTR optimized and cardiomyopathy study, on be do a and biomarker type version we optimize to suspect have working rapid a somewhat are did a an maybe will will that's those are concluded faster of population, in it's but be probably will NEURO-TTR we outcome the not and be whether of patients. lowering We study path on through think a Pfizer necessarily will there results longer -- whether Akcea there III not the real I smaller that their determined or like the to necessarily we it's we focus version and a based that believe with that the regulators get from but

Jim Birchenough

announced to you'd suppose Brett drug. that for I we say, that, have their to would expect similar

Brett Monia

Yes.

Jim Birchenough

fair be to that Would say?

Brett Monia

to We the us, that it's discussing as we do and certainly so know, option option, that only it were Stan we the -- to team, going want have are absolutely… Akcea it's so [Ph] we definitely available that's you to consideration, Akcera under and

Stan Crooke

LICA way. pro-drug and it parasite think that, a to that and thing as direct and then I a truly used so be as is removed, drug TEGSEDI is we is could that delivery sequence same a or Another certainly to has it treated of it the the it pro fact to pro-drug in want the a that the add is formerly drug, GalNAc

Jim Birchenough

Thanks, guys.

Brett Monia

Jim. Thanks,

Operator

Please And ahead. Ritu go our comes from next Baral Cowen. from question

Ritu Baral

Hi, taking guys. for Thanks the question.

Just for the as efficacy NASH two structured readout remind Phase what the will [indiscernible] that II produced data Phase in of for and NASH, how X those be endpoints as one, trial? the end really well especially of the you at Akcea on program questions, can and

Stan Crooke

take that I'll Ritu.

two actual a expect certainly we the of the slightly and the And year, to later. get update fat primary different, but for populations are LICA. expect studies in we little assessment near the in liver data [indiscernible] both endpoint So is the MRI this future, [indiscernible]

we are we markers, looking also be fat, liver secondary and in a of -- we things, reductions a and quite metabolic and other tolerability number characteristics. other the course triglycerides some endpoints of and for will and number So looking safety at plasma of of variety a evaluating what have

Ritu Baral

In of of the seem MRI we that that PDFF difference NASH standard trials? safety I looks guess reconsideration

Stan Crooke

small learned become differences can they area course fat detect been relevantly fairly this Yes. in KYNAMRO liver effective fat, highly, in in is changes that over what how they standard I MRIs think liver time precision have the with have of high fat work liver doing and in We rapid. first are we've are, we've the and they're learned assisting

we highly other high along. effective moving of degree a in these are confidence have we have and So measure MRI for a measurements liver that drugs drugs fat the NASH

Ritu Baral

the certainly with what pathologies, about [indiscernible] you different the the NASH to where direct can do in think downstream? and benefit information and mechanism you fibrosis, maybe And the talk DGATX relation

Brett Monia

so pre-clinical looked fat and determines will other inflammation was syntheses as targets well of Based fatty to pathway we triglycerides best have a DGATX and did we that looking acid didn't with in the is data, target, within NASH. at extensive we that did of which that multiple to would synthesis be we luxuries with which reversal only those not most pathway at lead pre-clinical like and models plasma we NASH targets as platforms the that on DGATX, it's the attractive with of ability targets role markers we of of also the DGATX approval triglycerides impacting One our pathway and by the that on on. the see far that course examine we DGATX reversal for all lipids, cluster liver kinds in target but both of of saw things, determine

think to mechanism NASH, and glucose a glucose improve in aware, improve improve things. homeostasis, that as it impact will and it's sorts glucose, evidence of may you sensitivity the we're triglycerides So also not could lower as those which only pathway blocking be liver will synthesis I you fat

to triglycerides various and real targets the DGATX. us a in it's evaluation pathway within So led

Stan Crooke

as all typically attractive those way best these worked what process pathways trying liver focusing that liver in patient there the hepatitis fat are liver, and at several fat so then of populations multi-factors and in as Nash. fibrosis enzyme typically patients inhibits for explore diseases And in and mechanisms simply like being But for fixes to an factors by of the really Brett, of different free quite the feeds will course like, we have that for Phase most category these well. increases and fibrosis weren't and our that do different disease on metabolism this like we is everybody if in so progression on able of and that's and the important the then then are that metabolic case DGATX DGATX across maybe the and given multi second is is both and want triglyceride same patients, earlier an responsible think general to complicated think find but pursuing in who X, that structures I we I to to one not so all and processes. arm compare fibrosis X in accumulation also bit and looking the say we once and there lead find in I pathway to the in glucose why very we these of she different. have contribution formation one and that and factorial the that is strictly one inappropriate factors and of suspect be so development both driven kinds others think pathways We're of triglyceride are We to gamut also [indiscernible] targets targets, information are hit is behaviour we're that inflammation of that the an

Ritu Baral

guys. Thanks, helpful. very it, Got

Operator

Yale And Please Company. & ahead. Jen question the go next from comes Laidlaw from

Yale Jen

you colors and them other them going pivotal or terms just end next-gen has announced year timeline you sort toward pivotal give your that regard? little thanks the And terms the potentially and there has what's in and taking just maybe major of start impact start for a these next differences guys Good going thought bit the to of on back they're the afternoon, TTR questions. just products, to using the study any to Island that in that this of any of mentioned a study I reach sense, mean year, to market were for

Stan Crooke

what designed we so your aggressive TEGSEDI TTR-LICA to adverse an be that is the like, extremely of clinical the reduce I microform but to excited and profile think the about most have. great will we're LICA of they a matter performer in they certainly was leader as we that, TEGSEDI in yes marketplace. will pathway and think be end, We with think about question and the we have it's are going market developing the and is time does to our form profile. think will matter

Yale Jen

what that of your at question so correctly level and potentially marketing curious Okay, region. a will great. Canada, in That's I specific helpful. what why be I'm just patient and although currently potential another Canada remember the toward in is if launches just the is located type there effort that timeline at approve significant point for this

Stan Crooke

And we certainly in shouldn't to do be excellent Sarah take and in have ready can't we the Canada you are when think meaningful place, population of advantage and date is an yet you to be do today. patents a that launch future to of I can't so are and in finish to Yes, near certainly team opportunity. that correct. fully there in that's and a the I approval with which give in by progress FCS dialogue but but Canadian is team the we'll Canada ready authorities I able get going that regulatory

Yale Jen

Okay, great. congrats Thanks a lot and on progress. the

Stan Crooke

Thank everyone thanks your call. participating you, in interest in and for the

and provide a you. the to call announced you Details an comprehensive mentioned, able sure give event At York. be will Investor before I'm we on Day way coming be November soon, New details business. which to answer question but there holding will you be planned to if Friday out Brett please this have for on As will X in we on update

you So again soon. to talk you very much thank and

Operator

has concluded. The for conference today's now Thank attending presentation. you

now may disconnect. You

Ionis Pharmaceuticals (IONS) 7 Aug 182018 Q2 Earnings call transcript