ENTX - Earnings call transcript Q4 2018

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Operator

Greetings. Welcome to Entera Bio Fourth Quarter and Fiscal Year 2018 Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. I'd now turn the conference over to your host Michael Wood of LifeSci Advisors. Mr. begin. may you Wood,

Michael Wood

and joined Good the and and Entera conference Rosenzweig, call, XXXX operator. Executive Schwartz, joining and Officer year you us earnings Mira we're today's On on Chief Bio the The XXXX call. Dr. filed press well results also morning you, for Financial as Phil thank Chief everyone the company's release quarter the a a Earlier issued for today update. end is as on available and by Thank fourth website Officer. business SEC. the company release quarter full with year

financial, During the business expectations. strategies, making Private be XXXX. performance forward-looking of Reform Litigation the operating, Act of meaning that today's or call, Securities statements These or statements we'll include within future address

utility described a factors the clinical the clinical and XX-F property the company's position, based risks report with and SEC. uncertainties, timing on as filing approvals, of developments, actual cause current and of from those those management's risk the that the company's to belief contemplated to company's materially conduct intellectual position, expectations the are product financial well on results, uncertainties Form and as or in trials, the likelihood timing those of significant candidates, differ and regulatory statements the in annual Forward-looking include Those in are but risks not could limited, and future decisions business and statements. filings

Phil So, Phil, ahead. over Entera's please I'd to Chief Executive now like Schwartz. Officer Dr. turn to call the go

Phillip Schwartz

as talent clinical significant a considerable evolution our in programs, completed with very for NASDAQ, our key Board of all investors listing development research agreement management signed our Directors. and us and We the XXXX on was year call a our collaboration added conference the to and team growth Amgen, IPO a license Michael advanced you with company. thank and Bio. today you, joining Entera and public Thank and of the analysts important first for

look are strategy, updating develops. We on excited which progress and value. We important our there forward to year's create Entera's this year. perspective to year two intend are last with in you ways of the pleased we progress From the to start as

collaboration First, unique technology delivery of technology strategy molecules revenue deliver and that and oral proteins we payments access of us future licensing critical in our our with than We strategic provide of and continue powerful orally validation partnership offer technology, agreements by a us future drug form intend Any platform large our allows sources rather the exploring of partners. capital non-dilutive by injection. and potential and to with biotech royalty. milestone pharmaceutical leveraging could to to and

of granted The a several been other for indications. and of advancement indication second proprietary multibillion-dollar drug the designation, the well rare part our a hypoparathyroidism, osteoporosis, drug orphan opportunity strategy in have we which as pipeline is as

continue will as our to opportunistically themselves. We add to molecules they pipeline present new

developed rights is as and these We and large have fit. The out-license act have platform transport delivery we to therapeutics. of development the drug see product designed protect or can control and retain global full them we biological candidates to synergistically of molecules

pipeline we from are initial and Amgen of sales. various before agreement $XXX,XXX. the working years enzymes readily As option degraded by inflammatory Entera own will oral molecules they rapidly candidates the that myriad entering are selected two an and pipeline. we company the developing oral into can address technology mid-single-digits deals program announced large preference in that patient to aggregate that of their reminder, they and which challenges. with simply platform net testing these spent our fee to of and achievements payments has putting over absorbed in technology from convenience most Moreover, or pure select collaboration disease January as own form and and greater eligible biologic two These are based royalty is sales commercial value on can Under million injection. development exercise multibillion-dollar potential. them taking of other an the injectable for issues acids tract a illnesses low therapies select they believe therapeutic serious the from both for access greater $XXX for infused programs severe additional injection which the with as products not patient We in potential Amgen about that include of one production as to In an weeks are are for gastrointestinal of not they name encounter. these may a common stop of in the received after ranging There our its help by antibiotics, of These Amgen's of a five their induce our to injection be just has with may an highly almost as be reaction. which each delivered drugs classes in which tied fail. to milestones. their our XXXX, to a a biological of just our may and an neutralize Entera. Amgen's activity. injection cannot biopharmaceutical cause or are large platform are as two formal They few are some drug's they can programs molecule well The global to milestones power bring Entera level the payments partner technology possible was to a and recent December. up types illustrates to in ways include the the deal, underscored clinical labs options The site up collaboration of to preclinical few large of respected receive of Amgen, that drugs the to Amgen top currently in additional these

this molecules the done past. scientific is Amgen interesting molecules distinct the from are platform the which and a with not the parathyroid in have on compete larger we for Importantly, Amgen especially pipeline. focused our significantly level, has partnership that proprietary by our hormone drug work our in energies On will selected anything as

with Amgen We about partnerships. an and of and our future for excited validation our platform are serves technology it important as the believe potential partnership

We collaboration. in leverage discussions help forward We progress. results the biotech be ultimately for Potential partners pharmaceutical with are of non-dilutive and/or important on updating you to our proprietary needs molecules and multiple additional therapies we technology patients. to for look biological can and believe partners strategic our currently the their that pipeline enhance will large

commercially parathyroid with In we for density the and Let's now January regarding than the received incidence development on of gears our summarized we to the this graft the old shift bone hormone in the our the meeting positive XXXX, to (b)(X) fracture pathway pre-IND regulatory feedback of plan. focused were from minutes EBXXX The Entera's and is proprietary a formal primary received year. programs. rather of Starting trial in fracture usually with suggestions allow osteoporosis. use that which injection FDA guidance drug and mineral and FDA late save move density BMD, meeting The XXX Phase will to registration agency, enroll endpoint on fracture study a that in meeting a require endpoint endpoint. efficacy patients the required new running support treatment Based X the and drug only the many study available will interactions we X take endpoints significant and mineral a and drugs will required. the years PTH to Phase require fracture a to us of primary of as believe study costs time that trials not Clinical the be our This Forteo studies and compared complete. thousands application. bone our with prior

estimated believe and number the XXX will the X In approximately over decade can hour a about only endpoint that such we past approximately the in XXX comparable is win very Forteo. of in for study, are has U.S. osteoporosis being We patients currently at we postmenopausal $XX EBXXX underserved market. in the needed treatments. (b)(X) power is produce oral efficacy FDA concluded XXX and believe sources osteoporosis pharmacokinetic Oral therapies all drug ranging been the with opportunity the dose similar profile that hour to PTH. the us injectable is Entera's revenues has at there once-daily initiating PTH shown regarding Forteo, very XXX require the for to Phase approved men has women guided injectable sale to the any market of patients, a by to who have are Additionally, Forteo new is of be determined for This osteoporosis our or We of in which by we the driven high market week. market this in The the coming for order final that pill the expand this market achieve study a to industry of risk approved a note fractures. non-inferiority primarily and blood limited study, once which the will level seen it treatment share and significant potential be introduction study has to market billion.

program relatively determine Our to Phase what we be to to safety dose study. advance be be the both the X development study to short purpose study. optimal clinical ranging pivotal will our conduct in next and dose step a anticipate Xa The into Phase will

markers we'll last as anticipate second months trial year start for analyze the patients. and expect will XXX we approximately safety to this We this as well number six osteoporosis bone enrolling of density endpoints. of a and in and bone study quarter The mineral about

to Assuming a then XX-month Forteo Phase period old we study X PTH XXXX. over begin single the multicenter a conduct from favorable in with outcome Entera's will study, a comparing

XX,XXX calcium long-term patients a of with conditions kidney form including biological the levels vitamin the parathyroid program failure, since in of of in to critical a of parathyroid condition commercial in and cause the hormone hypoglycemia exhibit severe and United kidney drug, with in XXXX. may our move sufficient parathyroid activity. the calcium a Let's regulating PTH hormone, hormone amounts which of of Hypoparathyroidism Parathyroid oral in hormone may which deficiency high hyperphosphatemia in cardiovascular proprietary therapy the Hormone play the levels PTH produced low stones, role affects fails effects, been and is States. dementia. and gland blood levels of number blood. calcitonin Due available sometimes phosphorus approximately along parathyroid injection our in second even replacement has hypoparathyroidism. to to hormone Hypoparathyroidism phosphorus produce people the last abnormally rare D

of November, into that oral of and activates bloodstream PTH pathways Europe. our that to this is reported of known This PTH subjects have treating in oral oral has orphan period is to Phase Entera's XX which drug just in However, both significant an positively advantages Oral form patients been showed been as awarded calcium, has candidate very and induce we for condition. treated was impact oral the conducted and calcium biological well Phase vitamin positive the levels study disease. PTH chronic shown previous confirming serum one over delivered our which results act the pharmacodynamic studies in PTH and X the regulate. phosphate would and time four XX-hour the from In in in being pharmacokinetics States follows beyond we first United just hypoparathyroid this excellent D urinary a months X almost of and XX% that decrease as of believe part treating day. designation effectively PTH efficacy

were the this dose day therapy. PID. patients and administered the included of times And evaluated also high of a a second in Natpara, oral PTH PK/PD three treated replacement norm part available low study which commercially The PTH with has regimen

which for We our the provide anticipated of expect design pivotal results mid-XXXX, data will present of trial. by this clinical to input

officers Board a quality front, high personnel of we have the members. and On added number

Santora, guideline of much widely has M.D., drugs the to osteoporosis osteoporosis in Art and an leading the Ph.D., Arthur Chief the he the Dr. developing most other disorders. role majority XX Medical the Entera. prescribed experience Santora of of Dr. First, in development biotech of indicative than was industry new Officer career position development we for spent years September FDA with began and medication. his for at research of played his the the of XXXX, appointed career at including Fosamax, the for drugs. the where team approval of clinical in Santora important regulatory Merck clinical osteoporosis responsible of more

pharmaceutical director therapeutic and really our was operational, of experience, level. include of due Entera's of are last as at Laboratories of this held leadership January appointed wealth the He of major having a Chairman On Art as Ostrov brings Pharmaceuticals. Teva we Forest positions In number and Board. CFO a are of public Gerry him and time new CEO join Chairmanship success company at J&J's that AllianceBernstein to a thrilled business appointed Gerry of pharmaceutical President several to Director finance, of a the experience Lieberman, Gerald our sector. the in of Lomb. year, & to the tremendous Health have independent Bausch companies welcome Board, has also from world's We our executive this on Moreover, Gerry Care the leading and of of Fidelity Directors excited including team. and August. been Board including extensive Gerald his our and expertise the We have team companies the power has to Investment the corporate

until and other Mira announced will Finally, will Officer our has to Rosenzweig; recently Mira serve mid-April. to as of as company mid-April continue CFO opportunities be her Financial served CFO we in XXXX the Entera's home. pursue Chief leaving to from professional closer

appreciative to year. including in completion several on the Entera successful of ventures. IPO her progress very our professional of contributions success wish the her over the NASDAQ last significant the past of are We continued Mira's years We

We process would new a review a hired. have following I turn replacement that, the [indiscernible] to the a Mira and financials. company like to mid-April over initiated we retained of call XX.XX to is have appoint CFO Mira? until CFO outsourced in and With our of for a

Mira Rosenzweig

the in I Phillip involved great year. Thank in with Entera's rest to five you, like the future. wish sincerely employees and excellence everyone. would thank the hello in I past opportunity them Phillip and success to Entera the work for of

We agreements December to expenses was the certain and Amgen XX-F ended primarily Phillip under in XXst, year year studies clinical any fee December have Amgen. for for appearing $XXX,XXX results of The ended XXst, for XXXX clinical for today. capabilities earlier not as million XXXX revenues XXXX financial Research from were the agreement December of our be will production which ended the Revenues XXXX our year filed received earlier. of statements signing and million. we were signed of activities. with $X.X the for XXXX increase and today $XXX,XXX advancement $X.X in $X.X XXst, ended full filed recognized $XXX,XXX. mentioned the expenses compared and to XXst, development year an with Our right manufacturing The for did increase excess due December increase materials, an an pre-clinical million revenues

loss or shares through at of recorded the fair for and to and a ended expenses income of million X loan, compared warrants ordinary preferred Financial fees share-based were to financing XXst, liability also ended increase associated classified XXst, shares year in year Phase and an year XXst, expenses compared was equity. XXXX to to IPO when The for share fair our million value from increase in million salaries were resulted preferred XXXX. the and efforts, PK/PD an for Financial increase services, the converted XXst, CROs related clinical expenses to our for and financial expenses. and payments addition, up XXst, profit administrative value legal In increase ended related employee expenses R&D the other $X.X to mainly in trial compensation net December December convertible subcontractors $X.X were were performance million. purchase $X.X primarily as income share-based and regulatory matters. with XXXX G&A the the the consulting decrease mainly ended General was the ended the in expenses as net for ordinary including in change year $X.X expenses. December an to insurance they year warrants that in and There XXXX was by and of XXXX, decrease for shares decrease December accounting due the million offset $X.X in to until compensation December

loss. both In fair the profit the the addition, in company's for that financial and as value issued IPO recorded liability a a at are change warrants of

which for million December completed and of XXXX loss million. comprehensive up ended was X.XXX of cost issuance purchase XXst, million consideration Our Xnd warrants $XX.X XXX,XXX receive XXXX. to for XXst, company IPO to ordinary On the we December year in $X.X million shares to July and the shares net compared offers year an $XX.X ordinary XXXX, the ended we

the cash capital and will XXst, turn December again need. our now Phillip. cash $XX.X continue of our plan, of as our balance XXXX, call our March was cash XXXX, was We balance our $X.X As intend working to and to million invest XX, resources in million. G&A I to R&D

Phillip Schwartz

you Thank Mira. very much,

progress we our that, now up We questions. our like the momentum call With to open in we forward. your forward on Operator? we are the you look really have to and going excited updating to business would about

Operator

question-and-answer you. Thank now We'll Thank session. you. [Operator be conducting Instructions] a

Our first proceed the your with question from of with Jason question. Maxim Please Group. McCarthy is line

Naureen Quibria

study actually Hi. on I Will wondering X it Jason done guess I program. Israel will reading in study. discussions program, the your a that with starting also U.S.? Good just Phase I be that you as Congrats for the Quibria actually morning. with regards EBXXX to with I wondering or And is on start you with and Naureen confirms to confirm the This X FDA you've only this also to done morning. be wanted be in now have want completed the I dose was Phase you'll it opposed that here just can first to was -- two. the do the progress. one

Phillip Schwartz

excellent an much. very Thanks question. It's

small in conducted that or Israel. relatively dose four in the about is changing output different to five be in ranging of study study density. be mineral three six the three the which study commencing extremely of months be centers and will on levels that at the at are second We're the people, looking I out first study. to XXX end bone going endpoint study will efficacy in different Phase predictive mentioned to density of the at be we're after going dose highly weeks which And that doses a regards That a study. coming be study of X the mineral will of As involves bone as drug the read which will terms markers study that bone

mentioned were do likelihood to that for question Phase Or us the Phase study. we a or probability is FDA ask have to addresses centers around XX-F would that some X as reason and it United This to that Phase you would then of is unusual the Phase XXX an numerous If study effects terms X regards just for profile the or or whether X the I your that results see X in come have somewhere of us okay? there an Phase one Do on do additional what X around the FDA good in in Phase question. be of to would patients States briefly X the to the the would add X obviously X European be X As Phase would data. X two XXX the pivotal ambiguous study the phase If to on study is not we that our they bone just might data on we do high study. involve our then Union the of one Phase if Phase clarity that (b)(X). and another allow is have would onto likely data dependent in our additional terms hope Phase of only confirmatory X perhaps?

Naureen Quibria

can indications little collaboration you And you pursue? little the more so provide that's Yes, they that a on much. just And color Thank may the helpful. to are you Amgen bit? the able describe very

Phillip Schwartz

in the injection space. the we being drugs under otherwise could mentioned can to confidentiality. are we're is general Whatever involved. focus of which an factors sort utilize No. and able the various review in because to we tell alluded that We the in that to I of We're unfortunately. inflammatory documents. utilized say you able attached not Amgen collaboration as be for as the of her can't XX-F too it's We can't revealed the that

that works they in my injection So, can't which mentioned discussions myriad of in a believe of opening a in therapeutically it reasons words well they I other remarks. an as any but originally give it's drug extremely for one my

Naureen Quibria

helpful. very Sure. Yes. And that's

might So, might think year be within a do you report similar able to lot? you be exacting partnerships this that

Phillip Schwartz

possible. It's

to We no partners. a And different are of of probability say agreements in the We're usually possible. because we these what months it's take would gone with has the partners, guarantee of we're that but obviously I number and things multiple type future. optimistic will a with execute in dealing though. discussions probability sign definitely up potential of have number of

Naureen Quibria

have I question EBXXX regards just And the one with to Sure. last program.

stated likely the You out report from with the know would mid-XXXX. X you that results Phase portion

if to So, by X of the positive, a it's expect the year? initiate end Phase would you

Phillip Schwartz

be our But this theoretically in bandwidth At by even our company That think really it like limited priority. and that possible. is of would our osteoporosis probably prioritization. point be I in would feel we size our time of a terms

So, this the have like But capital we may significantly to be start mentioned. to point that company to Phase clinical partner We just drugs right then go and at try on that time, two planning partner if and osteoporosis also to deal would ahead X not sufficient to simultaneously doing would as able that. I trials the try we in we're with enlarge away. drug we

Naureen Quibria

Thank it so All for That's you much. right. me.

Phillip Schwartz

Thank you.

Operator

management further remarks. like Thank turn the this to I’d to for you. At back floor time,

Phillip Schwartz

should I thank other would and and everyone call a good later the good day. Thank so joining much. to great for reporting things like the have more in to forward look everyone and you news year,

Operator

today's concludes This you. Thank conference.

participation. your your may this Thank you time. lines You disconnect for at

Entera Bio (ENTX) 28 Mar 192018 Q4 Earnings call transcript