TTNP - Earnings call transcript Q4 2017 | Titan Pharmaceuticals, Inc.

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Operator

Thank you for holding, and welcome to the Titan Pharmaceuticals Fourth Quarter and Full Year 2017 Financial Results Conference Call. [Operator Instructions]. Please be advised that this call is being taped at the company's request and will be archived on the company's website starting later today. At this time, I would like to turn the call over to Sunil Bhonsle, President and CEO of Titan Pharmaceuticals. Please go ahead.

Sunil Bhonsle

thank for and us. Rachel, you, you joining all Thank XXXX, review Pharmaceuticals operational and Welcome update XX, Titan to our year provide financial business. on December quarter to the fourth call and an the results ended and for

to begin, our Form of this on morning you we at this summary on the with be results SEC. our Before and press inform annual morning release a filed issued XXXX that titanpharm.com. the can wanted I website report XX-K we And the found provides

Joining me the financial today before Chief But Vice call and results Jennifer Vice Kate the Marc Crowley, Rubin, from update Finance. the review will Kiernan and Dr. on Beebe, we cautions provide an Titan get our the Development President company, Dr. Brian required of are Officer; into and Executive on statements. regarding the Chairman; President of Executive forward-looking details

Jennifer Kiernan

disclaim financial not actual any everyone discussed Section may and XXXX. facts. matters statements of Thank risks regulatory and cause the back of on and to to statements certain which our of events, relating obligation patent Section and intellectual or the relating Act that contained you, any to, development to programs the change those conditions forward-looking information, circumstances include any stock statement that is development, our drug could expressly Act based, risks and testing, not Exchange Securities changes commercialization any could historical matters; conditions reflect any production current of or that uncertainties marketing required product Such any uncertainties differ to than and management's in revisions by you, XXA price. the that publicly herein results business, materially and updates property agreements Securities are statements of to expectations We the be Probuphine; results, undertaking Such our statements remind but process; And Sunil. of from other include, operating or will contain except relationships. the other to release are candidates; strategic limited meaning that involve and Factors approval statements to as expectations, XXXX to historical want statements I our affect now negatively XXE any within or Sunil. any such of in law. forward-looking today and

Sunil Bhonsle

Thank you.

Dr. Dr. We Then will our on that product the who Chairman, update I with brief summarize Crowley Marc the opening will an an financial follow our provide start your will Brian before call pipeline. And Kate recap overview questions. the with with call will from Executive for Beebe, Rubin. will a close results.

get Marc. Let's started,

Marc Rubin

and materialized quarter everybody. of briefly year. begin Thank course that measured, commercialization issues to came Thank some you we the like full to and say, launch very actually as related welcome uptick limited Suffice much, discussing first joining be adoption would you the the of it Probuphine significant commercial I'd of Braeburn by the over steady XXXX, ongoing the to of Probuphine today. Probuphine. of When of us that a disappointment. Sunil, its for in but the the commenced expected

to paradigm the that steps But we in taking call, from that. adoption royalties report net Nevertheless, fourth in in a the the agency in oral fourth for been of approvals sales quarter treatment help treatments. of earned encouraged the other to further to changing that XXXX within to its know, was The have and FDA Braeburn sales, of to the revenue of position these longer to second Probuphine discussed therapy would options increase the the issues the a that for third improve feedback was marketplace. half potential perspective. had rationale Braeburn number Indivior, the sales duration prior and to Probuphine new sales, retrospect, monetary and overcome of quarter's. on drug they significantly was January. one and the Braeburn it indicated of we near-term applications had our from in seemed quarter of and quarter landscape As indicated the contributed continue increase A buprenorphine some shift from could impediments third the investor then injection impact. reversal The of framework submitted by products, very depot were as that obviously, decline you did was to from compared hope will Braeburn that treatment were daily procedure-oriented modest in of dashed there modest our by the We Braeburn's the central the strategy at by part of sequential

Probuphine release addressing a neurobiologic to and confirmed Braeburn's Braeburn reductions. acute in were a complete soon. it is from for the bode disorder marketing the therapy. In for U.S. use provided preliminary more treatment, we disease Those late with with that years, stage. daily if Indivior's depot We rights soon product. while approved Unfortunately, agency Braeburn arrangement be adoption softer, come where and subdermal mutually our you product X-month belief the commercialization Even response chronic was return maintenance into would treatment maintenance received entered patients focus, staff other natural handoff opioid and to for are Braeburn CRL to period was dosing the as the a or would discussions by As the of satisfactory primary hope injection injections extended depot as entered well for that talks implant its significant by letter, our to there in a requires which a between that dynamic words, sales understandably CRL, will the ongoing FDA, from January. know, become often ongoing

keep obviously, those will, as discussions We progress. you updated

a to strongly Probuphine believe an has start, as all to we role combating while help United both control the of partnership opioid and are and forward strong Probuphine successful drive So we important with in it's the epidemic regain the of process a describe in important play we to its States internationally. that and would note, soft Molteni. following success that what very the in building U.S, addiction, to I looking to continue commercial think continuing Though

a Molteni by most property review you the related As European European Authorization Probuphine, ago. few Market of the is Medicines intellectual weeks know, that acquired Application MAA including under or the Agency to

specialized Molteni As directly have and East than new states, countries, of XX to a treatments has operates more the very network commercialize both its right Titan addiction of the strong track of Commonwealth, Africa. partners opioid Molteni and supplied both clinicians the through Middle record patients. for by in to exclusive Independent and a Probuphine countries in and success, bringing certain result, will North

Molteni's Importantly, and vision the and reflective future U.S, in confidence Molteni shares both belief Titan Titan's and role and current future in their in of our U.S. is the their for of support shared in vision investment both Europe internationally, for development Probuphine, and Probuphine, programs.

Molteni early-stage to Beebe, I'm programs, for With our in secure We including for pleased development that, are Kate? EMA collaborative well as as Probuphine future. Molteni Europe programs. and who now turn our with to very approval call to implant details Parkinson's working additional will on efforts ropinirole our our the Dr. with to we look towards going provide as over the be closely disease

Katherine Beebe

everyone. and Marc, details I you, product additional development to pipeline. very you of Thank am with pleased hi, our update

months. to portfolio As is XX drug long-term provide our our for you up is know, based delivery ProNeura which technology, proprietary continuous on to designed

diseases. We and of across are optimistic we ProNeura range committed the to chronic prospects are of a diverse

into the receive development XXXX. of the to Probuphine to the of with update treating competitors Probuphine on Office that not X opioid be MAA claims In generic containing start review. implant approval. Probuphine patent data notice This subdermal use date XXXX, data received And XXXX. of as in November if by In from able a EMA of Titan methods a Probuphine and covering will would reference October program the means European disorder Patent with will for allowance our until for patent protection approved to exclusivity buprenorphine. XXXX in an Let's potential from XX XXXX, centralized part provide a Europe. This for accepted Probuphine EMA, use the a for Europe years

stage and questions comments provide with of we While detail lot can't process, received Molteni questions. additional and the closely are reviewers, a review the I have this EMA of these to at I from that we confirm collaborating address actively can

the the within continue with submit responses We of in early this sometime reviewers our year. allowed the expect to timeframe and the will interaction fall

good Probuphine share we to this opportunities two Now spring, story. have very the

profile the of objectives announce implants established the May as implants, implant the their that's XX, is In at of is cohort the a Phase with dopamine also on symptoms XXXX, formulation using And the or naltrexone, oral will then the and at and pharmacokinetic ropinirole marketed Initial ProNeura ropinirole disorder. treatment. months poor syndrome. oral for scales. safety assessment for Society and explore treatment ropinirole Opiant ropinirole control. evaluate presented of Florida. for opioid the European continue and EUROPAD, year. a I/II will antagonist plus the the approved FDA for of part prevention oral feasibility agonist, primary overdose. individuals their to the spasms to to on including Currently, of This on data monthly known Psychopharmacology currently excited and this HCL, first longer, Conference, of symptoms will U.S. Opiate at disease crisis we the formulations on be or October First, deliver the leg and signs for and Treatment patients Association Addiction Patients potential antagonist to is designed and Pharmaceuticals with data And assessment quarter, an opioid in were first as approved treated be opioid XXth muscle Miami, tolerability Ropinirole the the prevention data only their months a are in in then half use expected stable more disease, XX, dosed fourth from of in of relapse restless relapse ropinirole continuously annual study and also American Poland. of by ropinirole on muscle tremors, in our is to L-dopa three The stiffness, for target Clinical This In will of of May depot Alkermes. dose first to signals gears now an collaboration meeting program. in we the second, Parkinson's available frequently switched Vivitrol this switching three a of Probuphine the treatment daily the characterize ropinirole advancing planned. opioid of Krakow of injection have disease is and disease-specific to patient symposium efficacy Parkinson's otherwise a implant is opioid trial as of Parkinson's presented

with is of duration treatment sustained for long-term overdose to product will the that relapse and X-month a goal Our provide recovery a a prevention window and death. develop for opioid

any and in drug Importantly, than are overdose other higher fatal type opioid-related of relapse significantly addiction.

those month its of highest. At will as many after fact, opioid of relapse of In do from XX% first the the which a overdose relapse while treatment during risk a within XX% least in experience sobriety, a XX% detoxification who recovery at a relapse those fatal so following discharge within week of program. is

demonstrated Titan's Medicine the brief XX long-term American during ProNeura-based malaria the Institute encouraging the nonclinical protection antimalarial a from Research our for atovaquone release at of session up the other ProNeura and Hygiene, Southwest programs. presented sustained from Society In November weeks. Now of of the drug malaria. prevention with Research Reed Tropical annual XXXX, update the of development evaluate poster to collaboration it with data just to the implants data and Walter These of Army for Institute, of on meeting and a

Now high is Reed pursuing into opportunities interest very to Institute are the at and in Army this program advance clinic. funding of they treatment Research, Walter this

for a across product for type in these conducted to the of we Currently, for hypothyroidism experiments few evaluate of product disease the nonclinical the liraglutide a activities, have past are feasibility treatment completing Kappa these to pilot some L-TX scale and variety testing addition other diabetes. of of implant implant pain. indications and we early different candidates include the chronic Agonist In a Opioid II Receptor

continuous to drug candidates Of allow, will believe Titan's we diseases of the updating our ProNeura-based safety offer a holds product and benefits. treatment great turn portfolio continue of candidates. these time now as early-stage and levels pursue Brian? that Brian. look a I'll We may And select medication for continued on develop the long-term platform in course, chronic long as which you the for call over periods blood the we or we to of maintaining resources ProNeura product over to of forward consistent prioritize delivery promise efficacy progress

Brian Crowley

million to million are of Total approximate. December XX, ended Probuphine period year Kate. a which in on A $XX.X quarter items. were XXXX. or consisting for this operating financial XXXX revenue $XX earlier the provided in Titan per press XX-K in therefore Form Please loss morning were $X.X expenses million $XX.X Probuphine. same today. the fourth quarter $XX,XXX summary I'm results the milestone compared XXXX, XXXX, compared compared full in we $X.XX details Net received of or with are Braeburn. $XX,XXX Thank sales and royalties in of you, XXXX, and This this the common expenses XXXX. and pardon earned a the R&D me. been from rounded loss XXXX, was $XXX,XXX. fourth with of our about have primarily G&A a note filed total compared In same in royalties compared in to just $X.X full from the At million million from approval year In the same sales the in Total year numbers and XXXX, per by ago. on in release key time, the quarter of net $X.X from I'll reported net to was for with SEC all few the in $X.XX available present with revenues net the the shareholders included that of with million $XX.X in $XX,XXX highlight issued This the of FDA operating expenses, were share of quarter Braeburn $X.X applicable of quarter million share fourth XXXX million earned

million compared XXXX, we For year, or cash income $X.XX approximately XXXX. the of per net the $X.XX cash full million or XXXX XX, net equivalents $X.X share was a for share December loss $XX.X per with had of At Molteni February We to million. prepayment million received $X sufficient from of of believe,, Horizon into $X.X XXXX operations following from in $X.X our and million the fund loan XXXX the our the XXXX. March third in quarter planned and is

to back pass I'll Now Sunil. call the

Sunil? Q&A of happy end have them any during I to questions, be you If address the will the at the presentation.

Sunil Bhonsle

you, as we return its heard strategies Thank can and continued had priority. partners end, we looking the that rights Marc, you've with to Brian, from a remains for that product. the grow to discussions the completing Brian. Kate confident To Probuphine and active and XXXX with potential in to commercialization into very Well, has our that XXXX. forward We place, right are the and that of Braeburn U.S. full our top remain

Titan record Molteni, and commercial strong which success track the of pleased very of focus in new markets Molteni's partnership We drug provide validation and it with milestones. commercializing with the increase of Titan to upon to an makes regulatory an as label partner ideal we and In $X.X and transaction, Probuphine's payment will receive additional initial million received for achievement million the product global potential about its outside innovative important pharmaceutical are on Probuphine's combined also to move pain serves certain addiction products, payments of strategic promise. our forward totaling to $X.X up launching work uptick.

mid-XXs. for net is of up Probuphine sales to Additionally, teens percentage earn the Molteni XX markets the to Titan low this in out of from in entitled ranges on receive and payments the years

So it's a amount. quite substantial

debt. million Titan's strategic XXXX purchasing July of the balance administrative of this Titan closing and convert indirect Horizon. also at loan which transaction, shares with majority and control was Molteni that stock $X.X Molteni million payment $X.XX importantly, under with in into share, Titan's periods collateral to investment outstanding price the connection In at common obligation under principal made December premium the XXXX. circumstances, was the per and appointed of Molteni owed agreement interest-only $X by price XX, a debt transaction, a to As conversion part an its and assumed the the to time. agent And extended forbearance decent portion were of has the right, certain of the of

Titan. point is Probuphine important in of completed from about future this partnership as to be marks more just and options for growth that commercial success Molteni the So and evident resources with elements strengthen includes these it the our and Molteni in potential execute important Probuphine's advance inflection strategy continuing than is additional to pipeline commercializing our transactions, believe balance U.S. significant our stockholder value expects sheet, outside to other the us us a flexibility strategic Titan. We to our help financial of new driving provided a position that that products. The better to of ProNeura-based further to and enables evaluate

we and very based programs mentioned, our remain stockholders of both We for and Kate intend pipeline building As chronic remarks clinical today. our with the prospect for of other treatment prepared select based development we platform and product committed and to for ProNeura enthusiastic achievements ProNeura-based the about products. to our pursue the remain value diseases. This our on our on priorities Probuphine adding concludes resources,

we the from call take to so questions And participants. ready Rachel, are

Operator

[Operator Instructions].

comes from Roth first capital. Scott question The with Henry

Scott Henry

of Couple questions. guess, Probuphine. I starting with

how of force. a how about be of quarters, think smallest them I'm timeline going I get of not to specific think XXXX? there'll just for down? as anything should end-user sales parameters. resolution trying think we of next Or the we should a think sales couple flat? kind to sense know with about Braeburn? general they Should be have we just any I second, but should what First, to about you're a of know And

Sunil Bhonsle

Braeburn about reacquiring discussions and the Scott. Clearly, rights. with we Sure, Probuphine started some

to our been Probuphine. not on Braeburn the continuing that also discussions, where that CRL from part as need with same had the stage, the were that receive, can FDA time, but also at some a that they we at And looking indeed dialogue with Now the we of interacting to needed Probuphine on certain only the at point things make appropriate is there that FDA, onwards. they on be complete

have things these the timeline what of would all So into be. played

know, first that transactions. everything we conclude few the having quickly, we be to you stage access was directly was a with all our the days as agreements Now And is progress wanted We Braeburn first our where to priority finalized. are want completed, at this only with with to product Molteni the in clearly, ago which want able transitionary to completing dialogue at the to and that period. and a been place, look really have

period product next make I if in And It But expect of sales off continues Hopefully, the continuing Now the I a couple be The terms the going sense. those continue. companies. that so Timing as that used they much during a needed, a be product can Braeburn support you continue. to is some field there -- both is product support a in continue without this not there that from quarters, good will to smooth that transition. that smooth tell be that and but this wise, a and is envision is is specific be and a for broad -- on. transition all and medical support expect to for and as a today is hope quarter, timeline we is really that support sales to stage of during are to be on, things is Probuphine are progress low, the able to enough the supported that going of will support within is is this able force that has be terms to timelines we there transition it period it's transition. still so way these we everyone there been some perspective quarter, will Clearly, where Braeburn where will pretty that the the provides the eliminated it we market. product will be coming and

Scott Henry

G&A R&D. helpful, very perhaps 'XX? about And Should QX. QX relative 'XX? downtick QX, for I mean, we bumps where I idea we trying side, a think then of representative about in think Should think QX we representative back spending I to XXXX, of like about for when think about 'XX should is That was get about G&A level should we the on in I Sunil. think, guess, up R&D think certain Just an that? as And to of how as QX more ?

Sunil Bhonsle

at -- certainly think No, way to is Yes. answer. the most the the look easier best that I G&A

instance, varies be If XXXX for Mostly it total are we you are quarter, and about flat expect some. look otherwise, But -- the we for would so at happening. in full it significant through pay typically up. same because year's bumps insurance certainly the XXXX. to the year. for changes the There on, pretty expenses, Quarter-to-quarter have the first to the G&A no so some stays that of it it

the of R&D right available remainder the also of the terms by in will expenses driven be expenses, really resources Now now. the

We are Parkinson's the that is clinical study on. going to committed

well, really how expect We will the resources. from data first the with information have further half, commit tell will in proceed and we that us that as we how provide will that which much of to of terms level during some

will more look amounts, this than resources any would will what and spent at basically not are they have ropinirole in be of that in XXXX. clearly, terms I probably in So behind for the be study already we R&D the dollars,

Scott Henry

think about question, for Great. think we the the final should far how market of As that? relative Okay. as U.S., Probuphine then to Europe demand. magnitude in the about And when we

Sunil Bhonsle

there it some pricing of it of of in takes part will all, would early and on, following on, and time. XXXX. so in goes everything countries approval if I expect first Sure. be so wise planned, approval as that, timeline to then getting And such The is so and approach Molteni taking that specific Europe, course, of terms additional are as requirements

Molteni, specialty set Probuphine that product is precise In a a very to terms it for for is of of population. meant as thrust provide patient the

in based it's a these So believe setting. for not that, they they every countries. patient pricing And on in premium that get can

so, to the going really U.S. is markets climb the project. are about mean, a only to what obviously, may of right total And I it a is too market, little XX-plus that percent terms now. represent, dollars to in it be in gradual compared Europe early

We will certainly I as we it course, Europe provide Molteni's for provide of strategy the to get what reasons. some targeted and They, product so and all would of guidance what numbers closer better be made countries of initially commercializing and in idea and and patient rightfully competitive haven't part well. is mean, on this so, plans. public as

that closer So provide as we to really we to it, you. get will

Operator

next The Vandermosten John Cap Research. Small Zacks comes with question from

John Vandermosten

to changing related and thinking hands, also on wanted in another distributor? Probuphine to terms perhaps ask terms passed of it transition I'm about costs to potentially I and upfronts, capital then and developer, if in needs it's of

Sunil Bhonsle

in transition going are these are key that right through now this working obviously, mean, out questions ourselves I period. Sure. in we the

me you that on -- early perspective you numbers. will give specific precise a provide, as give than more but very things are broader it's to cannot as little Let too these very it costs, rather progress, a I sort of

to what being a the patients during approach initial extremely this taken partner U.S. or so is that can standpoint committed What and the they in the Probuphine of can the Right while and entities hands. are Braeburn Our the goal behind in marketed who the by to is the that during distribution new provide that is a any and resources a be put built will commercial in that provides process, really to all a needs new dialogue has very reposition in way. up now, a above that from within to change. or how targeted in period Probuphine limited a clearly are transitionary here right way, be our Probuphine doesn't, way suffer right assistance up

we a Kate's those require available all expertise we, the way obviously, combination technical it. will will entities. group transitionary a is, So And resources, and in clearly, some during we resources period the of expect to this and side, be devote in it and put Braeburn best supply-side, to have this that other of from from to

the at that's So now. right where stage we're

John Vandermosten

those that's is lot of withdrawing a lot guess, there's way helpful. there's maintain what's transition? of, developed providers. there and is implant a the that then Might And to a be Braeburn? equipment for by the lost in used of implementation Okay, so I And and the been also any far

Sunil Bhonsle

Absolutely, like John. as those the from over clamps instruments, for and things of plants, other Titan mean, and the to applicators will Braeburn instance needed. all I that, transition entities, the eggs,

so the lines there that process manufacturer in to way standpoint that either. the with DPT, is there continue of relationship of in in at own continued side We that and manufacturing Titan because contracts ongoing done has ourselves, to and has from on our from have of and and nothing is any suppliers have terms things. in with DPT have an -- so equipment on supply the supply world, to that in our that will we a interest rest continued so so And of the change be contract won't missed this transition and the

a transition. So smooth expect to this I be

the product of entities. equipment as new All there well that possibly be over as the transition of into inventory is available will to

John Vandermosten

slow Okay. agreement is been potentially there? now. is maintain you're And the that new there this right with Candida, But there to that? does progress Knight in on and it had the potential update I obviously, date. and process And partner new this up as then, Is course, know of any

Sunil Bhonsle

think have Knight from Health the has moving originally. this support up Canada, have the especially people our Health assuming CMC on. summer for It we stage, regulatory the when to in I response timeframe been Knight along everything come was Knight application involved, Canada. an by at And all agreement with and expected is filed that Therapeutics. Braeburn. side is sublicensed us has with the questions have developed that that provided so authorities, Since for the product wise be that Braeburn approval. would from timeline

it it. will we final gets and How know that sublicense continue transition is So clearly from the to out, agreement support setting. Knight the Braeburn worked progressing we in

We haven't to or Knight specifically or worked to interested. back some out happen. whether that clearly, will how But other entities comes Titan that and interested we are is

So out everybody. it for that we sure make will works

John Vandermosten

well. Okay, have the particular? items that of there particular some we crisis Or And pipeline? just you're Probuphine there lot seen is in to in a that that news last that's opioid as sticks close for come months. fighting on out, seeing other the the Feds from helpful out anything out in of helpful the the in out, might And be

Katherine Beebe

recent you John. namely really This observation this increasing news for pace. good crisis, develop provide made. and government Kate. pressure that that question grow the treatments epidemic. The money continuing pay this additional trying and and to That's and news is Federal agencies all recently, for additional and to of frightening other has to that And charged services pay bad That's the for FDA to there is solving companies a on course, good made to to with other is treatment, is the related very is to resources at help in NIDA news. partner with is them to fact and the have on it a good Government to Yes, evidence

Operator

to over And to marks. conclude like question-and-answer Sunil back our any closing this will would Bhonsle for I conference session. the turn

Sunil Bhonsle

today. Thank the Rachel. in participating you, you, everyone, for Thank call

our all but at company the believe very of period and staff you a downs, making the continue and committed our I we it, to we this to believe this. we support and at that in Titan. has and has working the been can board can Titan accomplish and we we management the been to wanted acknowledge ups of and hard progress and provide Before And close, is sure people

So period, we during come. appreciate updates your really truly to support this and you the year to look to in forward providing

you. thank So

Operator

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

now You may disconnect.

Titan Pharmaceuticals (TTNP) 2 Apr 182017 Q4 Earnings call transcript