ZEAL - Earnings call transcript Q2 2021

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Matt Dallas

Thank you, operator. Welcome and thank you for joining us today to discuss Zealand’s First Half Results for 2021. I am Matt Dallas, Senior Vice President and Chief Financial Officer of Zealand. With me today are Zealand’s President and Chief Executive Officer, Emmanuel Dulac; and Chief Medical Officer and Head of Development, Adam Steensberg. After the prepared remarks, we will open the call to take your questions.

Pharma your Sanders, session. questions Zealand available also of take to during President U.S., will Frank be Our the Q&A

to can to zealandpharma.com. as I company on by recent related be valid no making assumes to out find only them, law. additional that obligation will uncertainties. You information are These statements Dulac. complete supporting Please are required of to factors. refer the for and subject that and the company announcement Emmanuel we over picture filings except our and update and like of I’d more and will at today forward-looking a other to risks point as website CEO, call the President risks statements With turn that,

Emmanuel Dulac

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will with depth includes For diabetes on drugs We which candidates disease makes BI; programs. and the late-stage continued X focused help pipeline familiar have shown defined our our manage two therapeutic late-stage four expertise newly appreciate and us those with pipeline, of progress mid, collaboration pipeline and better programs; franchise, are our Amylin The our in to marketed allows with areas, wider us two area they focus reach programs; now our obesity slide. portfolio. improve areas and with of which potential GIP rare our the each four Type two this the mid-stage and one and of

a acceleration within We pipeline finally, are of forward. second now expecting promising of build investments focus of areas inflammation data see shows CMO clinical will is prioritize and and of Research the year, Development, discuss in and our readouts initiation and our in which in turn of Adam these our this the The to our activities new research Adam? detail. going I half with plan our potentially early, obesity how assets. over greater four but franchise, is it reflection clearly to Head pipeline we in and Steensberg, productive our to how to

Adam Steensberg

the I really Thank that you, next programs slide. across progress I to pleased on the with forward pipeline updates Emmanuel. look more making are share the here we am see you And and

X. Slide to go please So,

of be a that building medical however, diabetes beginning organization well-positioned Our our of engaging further mission with introduction the has solutions need for of The and rescue equipped pleased people paradigm Zegalogue to to ahead Zegalogue to only of busy medical affairs with Zegalogue, is Type hypoglycemia. in create early I am the launch X with marks the severe more allow confidence shift in management. been community the feedback

the on improvements management or bihormonal burden the the of of initiated addressed we average, And be to area represent we at that, a remains in insulin many decade, that an of last In disease suggest can their patients artificial use those, of holds U.S. investigating patients the among glycemic While a of and pancreas an features XX% also introduction believe quarter, goals system with and dasiglucagon Phase the only it in potential studies very our exercise-induced of to we life. In at over its have seen and the achieved these is unique CGMs and allowing the last patients with unmet target end quality all medical glycemic insulin of improve help the high. in low-dose a other outpatient low-dose great looking in either lot of view, pen pen achieve now a glycemic time believe equation anxiety we dasiglucagon dasiglucagon. significant which drives start trial X hypoglycemia, which by the and needs. pumps,

On the the Bionics in bihormonal that happy iLet Phase are pancreas we on year. of trial this artificial remains program Beta the dasiglucagon last completed later quarter X front, to initiating track and we in-use compatibility pump the test see for

and the Following providing X Altogether, FDA continued on next and forward in positive have and these diabetes bowel progress in Please as in into congenital a turn reflect from Both meeting, end-of-Phase expectations. good of we commitment we the And suffering disease look have hyperinsulinism lives we indications this program, XX. for believe difference syndrome. make rare further quarters. programs to Zealand’s a updates short our Slide on medical people our of the efforts we areas large represent our to conditions. alignment dialogue need unmet with

For development. X we are programs, both concluding the Phase

expect Slide XX, well results X In primary Xb dosing At X who SBS the in a X, of from completed also intestinal investigating steps be program our SBS Later for X Phase you for will absorption which first to gastrointestinal This to next glepaglutide of the support remains generated X And Slide go is potential see glepaglutide pivotal On overview and FDA. where initiated we the in the XX, result, safety endpoint, the as cohort with and you efforts X, you have to XXXX. that in generate last potential year. on quarter, pen being X auto-injector a the program later will fluid neonates energy. and If which XX we of to long-acting our in effects to we investigated X, dapiglutide, Phase is years of dual to to EASE as we patients the Slide its and up track in on results Phase from global trial as trials. dosing. the range submission for diseases. treatment abstract to this the ongoing year. Slide from as X to and utilize can If trial this from the and dasiglucagon agonist GLP-X wider condition. data full meets the from obesity, XX can a Please growing the see fourth provides those the the out already this of EASE this CHI we X.X program once-weekly dose announce and SBS track quarter, year, read second on is address completed have quarter molecule. In efficacy and Phase expect to time, SBS patients we our for NDA a go study study last for the glepaglutide evaluate in utilized study of long-term Phase later X to development EASE expect trial. this results the a which results an in

and intubations achieved with can medical lagged treatments treatments percentages. loss are medical approved far loss the into weight for a obesity aspirations have seeing surgical for that provide, what recently mid-teens behind, While weight we people’s change now

GLP-X and strong the we both which of metabolic conference Boehringer, believe complex Slide agonist into all by future designing of the where and receptor the that At Xb and November, X We look with to XXXXXX, glucagon molecule, will is weight announce focus to agonists. may believe next single candidate obesity. enrollment where the disorder, present a of we strong Please go commitment NASH into a is functions Week in outcome the peptide promising peptide to on two single-acting On to around loss first targets Slide Phase metabolic obesity completed BI other co-formulated building a XX, the partner, changed needed Zealand, treatment since acts towards diseases, that to Type shared in our forward like take in X be to our address that are approach we centers trial. potentially diabetes. X this Phase are we our excited level. needs Amylin multiple molecule the as target However, a medical and supporting to has obesity, new trials, combination BI our Obesity XX,

see excited the as first potential to Cagrilintide Amylin Amylin clinical our now a in will over known and have our Dallas, GIP bring to we ZPXXXX containing analog been Matt? expect with X monotherapy It loss our both a molecules. and the slide. turn for CFO, over combination co-formulation has presented X a weight designed PFM to through GLP-X therapy into loss financials. long year. has this this number X later preclinical allows Matt trials go This with to this We been molecule half-life half with to that In and have weight another plasma shown and left in Phase of models. as I of analog Phase development of regard, ban as potential semaglutide a

Matt Dallas

wearable Slide the Slide the or programs. it primarily strong and by compares was driven On the growing U.S. programs, same of V-Go in Zegalogue the income Net million will first DKKXXX.X $XX marketable and delivery the milestones. or Total half billion Sanofi. $XX.X as through quarter, million. marketing in XX, cash, or with period our loss through to to our the net while sales million. of revenue how illustrates late-stage and financial a XXXX The Thanks, continued of insulin V-Go XXXX. half end R&D equivalents the DKKXXX.X see related net result revenue, partnership cash operating $XXX upcoming Adam. is This half was and for infrastructure the commercial and of costs million, half $XX.X or commercial the expenses support of DKKXXX.X The as support to for you we funding product Alexion to statement were DKKX.X the costs XX million operating mainly first to million. our ability company primarily position several investments. securities from well had for device and collaboration revenue the key Zealand’s At the businesses our clinical related million

Turning or to what expenses Net our be expected of sales is be announced from in for XXXX financial billion, the no product revenue plus commercial million, Net our financial products XX%. our plus changes guidance was minus on XX%. XXXX, there from March. to are Slide to are guidance or XX, DKKXXX in expected DKKX.XX operating minus to

license from existing expect revenue agreements. We

However, will and not size to since now uncertain timing, such back I revenue we of such Emmanuel. provide is guidance intend because to that, revenue. it With on turn do

Emmanuel Dulac

Thanks, Matt. Adam. Thanks,

established – talking on questions I Before to positioned that want of that first we this the your ahead, are half year. in looking we taking well momentum to confident and we reiterate build the are

Thank of turn advance XXXX. five for need all. metabolic we now to therapeutics questions. and over we As continue you the our to indications our offering of work goal patients, across to it gastrointestinal it the products and will most, commercialized pipeline peptide to by next-generation bring I Zegalogue achieve operator

Operator

[Operator Your question & from Needham Thanks line first today Joseph comes of Stringer Instructions] sir. you, from Co. the

Joseph Stringer

Thanks our questions A everyone. couple Hi, of me. taking for questions. for

First marketed curious one could – other terms that if from they on of switching from Are know from then kits you on insight And products? is Zegalogue. sorry, but switching question on on early us second CHI. initial second the I syringe patients in some in give question just the it’s are products? auto-injector is the or launch,

trial that to if thinking Would Thank run a situation your Just outline could additional of trial? in or if you current still some discussions be with thinking? this? additional positive the you you’re trial in thinking your kind core Is what’s the where you on the any from with wondering your is trial. Phase on prior this Or considered it your registrational trial [indiscernible] on doing studies you. analysis based that a – X is need Emmanuel, conjunction is could mentioned regulators what current previous

Emmanuel Dulac

opportunity to Thank Frank you, launch, of Zegalogue for the is operation. to have Sanders Joseph. Maybe online, we the question President first who U.S. related the have

will CHI will And discussions take Adam then related actually so regulators. Frank take the Frank? and with to these questions questions related the

Frank Sanders

us the thank Emmanuel. the Thank for you, and question talk launch. opportunity about Joseph, the to you giving

mean, it’s I days. said, had you As early

it very some new into source of launch coming therapy seeing early, the do, segments to doing with bringing from areas, June. here category. sources We’re it’s patients And particular, saying all is just to we the they recovery reliable I the been around the X.X patients months that late wanted at favorable in clinical would from Zealand the patients. as to stand. by and around and And wanted which bit Zegalogue your around start board that said we has in, pleased meaningful they by we but across said we’re start very several – feedback mean very a we while these was teams saying where of HCPs question, relates of rapid, and would of are consistently we’re I profile, full rescue for are what across – executing business a in the the I the business, of and proud

of from these And to conversions room of newer rescue there Zegalogue. also is over are there. legacy a like maneuver patients therapy coming continue into kits lot And in grow products to of some

XX% still of prescription kits XXXX. that’s point total a that is data quarter is of in of legacy share second the as market the Just important the

plenty establish is the continue market, there share to convert much legacy So, continue kits. to of but from – within broader Zegalogue to room

with the move as to to a with forward to strong able we launch. we forward look where off and more report Pleased are are We data be start.

Adam Steensberg

from actually X X – trials would need the can the follow-up Adam. as – you to maybe to will out I second is primary will on confidence that data X NDA data, expect they And study question say contribute your comment And we second to we support our moment, But on can I trial CHI. need additional very out it say our We, not now. Okay. if in has approach anticipate we how that data Phase strong see at the a meaningful this Phase right course, increased – trial speak a if we need study. utilize is full come first we in endpoint of the is that to the the my do comes this the this would I to confidence then positive. And Phase from the we also data first would as set. this in

Joseph Stringer

Great. taking my questions. Thanks so much for

Operator

Thank you.

Suvannavejh comes Graig from of next line question Your from Sachs. Goldman the

Nick Hallatt

my And It’s thank taking Graig. for you Hi. Hallatt for on questions. Nick

a may glepaglutide, update offer And able current us ongoing Just how on XQ, the quick there? trial seeing are hear year? to balance mind versus bearing you rates enrollment And what environment? any seeing perhaps that progress COVID me on Thank we then you for on to update for in the you in you. one are expect are when an of the program

Emmanuel Dulac

a take Adam, you chance. can

Adam Steensberg

Thanks, this Yes. Adam is Nick, again.

the you more the then program year, which have confident also So, next we year, can can that last are are regards discussed to again, the – we we which just are for later And data expect, recruitment, our to expect basically in. guidance with year. you where call, back updates with And is pleased this. will we results in in precise. pre-COVID maintain recruitment, But – then on be really the but are the so updates to we at we we

Nick Hallatt

Okay. Thank you.

Operator

you. Thank

from from comes the Darout question next Your Etzer Guggenheim. line of

Etzer Darout

my for Thanks question. taking Great.

weight looked comment seen, that a November? you you have partner be you of on bit with sort you we the And read-throughs from data know some partnered all Just, saw for GLP-X/glucagon. the a if get we going And that I the BI, to help data this November any sort data that pretty could could presented is if and/or on program in of loss. Adam, little encouraging but will different see to in at Thanks. just on that program recent

Adam Steensberg

Thanks you can’t. I straight a And for I give question. could I very wish but answer, the

And of it’s commitment a a we three partnered here program. we Phase BI. What ongoing release We know, very you data – course, completed of Obesity our is encouraging which, will – a say with As if Week. strong one quarter. see, can from the also with but can they the is competing lot in this data noticed very on the enrollment reiterate program, see earlier that we BI you basically which earlier with to the encouraged see at the remain studies X excitement own we approach.

cannot more, hang you that’s I to unfortunately, forward in then share November. look So, – have but to and

Etzer Darout

It Great. good. Thanks. sounds

Operator

question [Operator Your Stanley. from comes Lebowitz Morgan next David line Instructions] of from the

David Lebowitz

Thank there question. When for gave the come? my towards us the for what look this when very to data Is steer next lack as time year would of visibility year you much you you be possibly might and XXXX you taking of could timing. XXXX, or in And point? during at it year, glepaglutide it

Adam Steensberg

because maintained more, want we We have to that the year we of just ‘XX even absolute specify clarity so... before

David Lebowitz

Later this year?

Adam Steensberg

you when in clarity more this will Later have year, ‘XX.

David Lebowitz

the comps Okay. dasiglucagon, when at be look we helpful. us should that the look and And there help might cadence going what are launch to guide That’s we forward? any of at

Frank Sanders

that Yes. one. could if Sanders. I Emmanuel, take This is Frank

Emmanuel Dulac

take please Yes, Yes. it.

Frank Sanders

Yes. you. Thank

is specifically, the around Zegalogue. question So, assuming I am

to that at. I look things a think – that couple is there So – obviously, and of

of one said, products of we of the that category a profile. we in – launching all, That And those and well-positioned the of launch couple strong in other unique the market stands First recent in provide category. is that believe of a signals a things rescue product the leading with are that therapy Zegalogue. are there performance along the of

be the – performance COVID. important as we it’s think to progression as the growth I overall volume important it’s able category. look the from the in market But the other recent emerge also watch emerge we of market share So, here at to growth of launches to

COVID. that suggests year-over-year by data grow Med the emerge from to market approximately we Symphony recent TRx example, as continues For XX%

picture as to think is combination look recent the there or progress insulin. on I we X there And the that And emerge. in on are are to is XX% patients second-generation be the big factors multiple well a launches performance U.S. that despite progressive million But are of how therapies. continues the daily of important as XXX,XXX here quarter-over-quarter at. rescue is one So, that that, doses approximately as will market of only growth

us there enter to a of room to So, a be with that’s lot market plenty is in of category for able opportunities. but growing, this

able in report throughout play our much more as first we and watch, So, will and to of to we launch. be progress is quarter

David Lebowitz

Thank my it. taking question. much Got for you very

Operator

you. Thank

hand Thank questions for back As closing you, at I like we the sir. to have further Dulac to this would no time, call comments. Emmanuel any

Emmanuel Dulac

And to with attending we for insightful your you. you Thank that, and questions. for all thank like would

questions, you If don’t to hesitate follow-up have us. any please contact

reply to And quickly. the of commitment sure team make to I will the saying and that you of the launch. We want proud really by execution am of I finish to to the

on track the and in our with the confidence pancreas. with artificial Bionics actually with HIFI progress AstraZeneca for well Phase our our shows on strategy, partnerships and bihormonal in have Beta with BI launch, X as partnerships CHI ongoing the We in and we glepaglutide are which with

today. And connecting you future you in on announcements again. coming to for you soon. thank Talk thank we forward look update. again, So to And and

Operator

gentlemen, for participating does you. that today. conclude Thank all Ladies your and you may disconnect. Thank you call and for now

Zealand Pharma A/S (ZLDPF) 12 Aug 212021 Q2 Earnings call transcript