TTNP - Earnings call transcript Q3 2017 | Titan Pharmaceuticals, Inc.

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Operator

Thank you for holding and welcome to the Titan Pharmaceuticals Third Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today’s remarks. 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 conference over to Sunil Bhonsle, President and CEO of Titan Pharmaceuticals. ahead. go Please

Sunil Bhonsle

recent and to Amy, and all joining XXXX for results Thank Titan thank Pharmaceuticals Welcome and of quarter the the financial updates. call us. for you, third you business to operational review

our results you be this Before we titanpharm.com. this summary morning website Form with provides filed to the found and the XXXX morning, the quarter a that SEC, we and third press wanted also begin, XX-Q I on it inform can our release of issued

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

Jennifer Kiernan

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

Sunil Bhonsle

Jennifer. you, Thank

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

So, get let’s Marc? started.

Dr. Marc Rubin

on a Thank based for the thank products, delivery I on update for quarter. revenue want technology. you to highlights our the all on you, Sunil, progress review and joining and of an by today decline of Probuphine our in for for quarter addressing long-term the portfolio our ProNeura business us drug begin continuous

with Advisory health depot and patients from treatment the If the opioid believe the the this for use away formulations, to current and to as next however adoption Committee both treatment treatment, did longer these year that her post-launch national especially to quarter. positive his the receiving the even very an have sales months uptake be in one, care provider Opioid and its surprised to positive enter use REMS and Mitigation as neurobiological Feedback have well as has well And reimbursement oral moment from the is monthly approve often Probuphine I by or stage. continue been programs, to negatively from votes as for patient as changing years. do that a of preauthorization is key to is related disease PDUFA procedure-oriented of ongoing access as dates companies FDA. in issues shift claim formulations probably of of third-party patient much-needed payers Braeburn We you know. two several life-changing opinion week, months, duration a by on is want by and and leaders of address to as indicates in disappointing ongoing weeks former or landscape a well monthly of take can issue, therapy to towards the daily the with products depot last companies’ impacted dynamic In received frustrating as options and of both an paradigm coverage feedback a submitted. treatment example the approved, time epidemic. timing level and Probuphine Risk Strategy for as Probuphine provider, buprenorphine. Evaluation insurance light Indivior would measured from the we that it take were kind or proscribed so, it formulations company of treatment weekly products treatments. disorder. disappointed requirements maintenance disorder or acceptance anticipate is Braeburn decline a requiring delay of and the we both certainly opioid While the a effect should and chronic with of for This potentially the for as should the a this

the ProNeura Probuphine development additional believe we product. to the long-term light expect the Probuphine current continue capital for to uptake programs. and advancing strongly we that continue we maintenance to-date, will of of of so, sales in patients of And can need medical of of benefit our in In believe course, prospects order from And for treatment. value the that XXXX the transitioning by half second to do we

for ProNeura or to financing including and our for Probuphine, We of are alternatives opportunities evaluating and possible potential pathways collaborations available one ex-U.S. more programs partnering strategies. us

are in fuller understanding shareholder addition I to strategic our the that aimed and assessing actively in that business mentioned you alternatives options available impediments that Importantly, to with want and a and assure the Braeburn Probuphine, of just to that discussions at value. these increase all to the is of can operative uptake with treatment providers Board addition I

We approval Dr. efforts want the Beebe to will details our now including our and the additional secure type as on our to you malaria informed. other prevention disease Kate? for partnerships for well to overdoes, provide pain, chronic the and to for diabetes, Parkinson’s as turn as keep programs programs and and in settings. early ropinirole call I implant our of development well over Probuphine stage as use chronic of hypothyroidism relapse disease opioid X prevention Europe

Dr. Kate Beebe

everyone. Thank you, Marc, and hi,

on ProNeura our continuous know proprietary designed is up diseases. We you is delivery to to for and of ProNeura diverse months. to long-term, which optimistic a provide range the technology, our remain across of chronic based As prospects committed drug portfolio XX

First, let start on outside me an with the United update Probuphine States. of

Probuphine Canada, that commercialization many know of in to holds retain to other the you Braeburn and rights U.S. Probuphine rights we Europe in and While territories.

Our plus our or U.S. Agency. on is initial is European week, representing with market the largest with for Europe, U.S. second we Probuphine Marketing focus Monday, Medicines the sales products for in outside market. about the MAA Authorization submitted of Probuphine-based X, the Application $X billion This November of which XX%

advice containing methods And covering who to We be Patent elsewhere. a use co-rapporteur At have protection to and and for Office patent partners treating advance dependence rapporteur Upon Titan buprenorphine. notice and patent Europe continued for provide XXXX, and from the MAA. commercial in from this in the October the for also have potential countries, same Europe XXXX. review lastly, with opioid the is for British application. with a subdermal leading Probuphine agencies our European for continued support issuance, will in implant with Irish into we received time, and received of a And our of allowance Probuphine expected claims both discussions development meaningfully scientific we discussions

XX Now, receive EMA, in means competitors part data of program. to date exclusivity by will reference a would the be This if from as to of of the Probuphine generic Probuphine approval. potential data able years development that addition, the approved not X

delivery cohort their daily also to Ropinirole have the disease. evaluate assessment ropinirole to long-term, like continuous and our poor of the ropinirole to disease designed are HCL Parkinson’s a potential and for spasms to efficacy their Now, first on of implant turning next for control. signals implant tolerability profile first XXXX in of for muscle targeted established ropinirole study ropinirole and for ropinirole disease-specific three treatment symptoms L-dopa stiffness, The Parkinson’s implants in objectives of oral completion signs program study. is the plus available treatment more ropinirole safety or of first muscle is from implants, expected switched the is symptoms primary tremors, dose both months the year. The patients ropinirole in our to patient leg stable currently Initial half X/X restless oral progressing. of the syndrome. a implant, study and frequently the dosed data in scale. the Parkinson’s and In oral the of treatment Phase treated of end of of the for the pharmacokinetic formulations for Patients trial using is the of disease and is agonist, ropinirole will dopamine of characterize we this and explore October,

is approved that for dose. announced only opioid monthly depot a assessment implant and for of to over instruction we the naltrexone. on feasibility an relapse are of opioid quarter, ProNeura-based antagonist a prevention opioid Opiant the This prevention a antagonist we with collaborating administer FDA subcutaneous also of relapse Pharmaceuticals Currently,

long-term will allow prevention. among a window disorder fatal higher be type providing Relapse for be relapse duration of goal significantly at other would and a least a opioid-free drug is with a to any overdose patients those with longer use than addiction. Our opioid most period, six-month to that develop critically for greater and recovery product and overdose

about XX% do as within week at from its The detox fatal XX% risk a of will within For discharging example, who of of a month as relapse. so treatment a in relapse, relapse least sobriety, those program. highest XX% during relapse at a is many those while after or recovery the a overdose of experience first

of of treatment non-addictive opioid a a of pain. inclusion several of candidates Early is being for non-clinical If for across evaluating crime a the chronic also Now, chronic testing opioid of our development pain. the for the treatment would and other portfolio. we’re different product for offer conducted Kappa indications analgesic potential the disease implant developed receptor variety approved, this feasibility successfully potential in

hypothyroidism. in the We optimization early presented of working its diabetes. study ProNeura are on and also type of liothyronine released providing months, liraglutide for the six L-TX important annual Victoza actively meeting potential known a Thyroid Association. on the otherwise a implant poster sustained non-clinical from during information testing implants American for for L-TX, ProNeura data in of more as dose delivery initial or The a development at for as than long-term Titan also the use adults for treatment of of X session continuously vitro formulation the subdermal dependently vivo

Medicine program and is long-term being of the American annual WRAIR In addition, Society the Research sustained Institute for Army as be Reed of These pursued presented candidates are product from protection drug XX session ProNeura and for WRAIR. during malaria. and of and malaria resources WRAIR data Tropical to fully & Research anti-malarial the prioritized allow. Titan, funded release collaboration from by at In poster Hygiene, This up the atovaquone conducted XXXX, to early demonstrating collaborating stage will or of November non-clinical weeks. this encouraging platform of prevention the evaluate Walter a Southwest Institute meeting

of which you treatment medication We of forward periods the over other long-term ProNeura-based the continuous may for or develop delivery on a long consistent as our holds diseases progress we portfolio of of chronic product updating ProNeura great look candidates. to drug Our safety offer in select for maintaining blood continued benefits. time platform levels health promise

over will turn to the I Brian? Now, call Brian.

Brian Crowley

Braeburn, The the an was quarter to the the and revenue XX-Q of $XX,XXX you, in approximately the the the I’ll press morning Kate. in available loan the on SEC. loss $X.X and with increase sales shareholders with third product this employee-related was was in compared of highlight of and just we quarter approximately million The million, expenses in non-cash we and At items. Form in royalties XXXX, $X.X compared from other results by details license earned provided in on expenses approximately Research few ProNeura the reported expenses, was Probuphine in XXXX associated approximately filed Thank summary XXXX related common a release are of approximately approximately which for our this third XXXX, of approximately net our In programs. with time, approximately expenses quarter development cash expenses. our financial of XXXX. million million. were operations XXXX expenses and million to million of other implant of fees compared of the General program million increases third with administrative development sufficient The approximately for $X.X in were $XX,XXX to increases August related $X.X of same third quarter approximately R&D compared equivalents or the or support $X.X with quarter third Horizon million, quarter of of primarily external expenses believe expenses for compensation ropinirole increase planned in and increase XXXX. $X.X XXXX quarter primarily had the $X.X third to per XXXX. net applicable a to in approximately quarter and and $X.XX third stock approximately XXXX. related cash through At the is $XX.X fund we share $X.XX loss of XX, September per share of with Net in

evaluating to Probuphine ProNeura various partnering more of or collaborations programs, We outside not for and but opportunities are strategies. the including, for limited of options, U.S., potential one financing funding our

I’ll back Sunil? Now, Sunil. pass the call to

Sunil Bhonsle

Thank you, Brian.

we While that disorder. patients patients has Probuphine The we the spoken the the the an the in to with have this important a to for third in treatment treat small, appear benefits Probuphine at opioid numbers to continue provide. are like to of indicate quarter, numbers continue the Probuphine. low while use we believe And role clinicians desire can product are with disappointed

doctors patients REMS has from inadequate restrictive adoption Probuphine. program and with hampered the of reimbursement However, providers insurance together their to

help understand product. the limiting address issues fully to to adoption establish as and Braeburn and with dialogue needed, sales strategies Probuphine in advance are of new We the

be release order closely as for will in also new, and landscape to the best We monitoring in treatment available the the extended position injections depot identify Probuphine become marketplace.

to in on Europe the November we pleased EMA allowance the a through also offer received filed XXXX. protection on patent that a for of that Probuphine And MAA we Probuphine also We’re announce notice X. with will for

continue we current have long-term daily over to this ProNeura-based Now, chronic products can treatments. platform continuous that simultaneously, advance the advantages belief other drug delivery with dosed our significant disease

quarter, of collaboration opioid technology opioid treatment During ropinirole disease. the and on symptoms overdose. Parkinson’s our Opiant to we for feasibility administer we first the of assessment of implant Pharmaceuticals the trial Phase our the signs a of a patient a third for X/X antagonist and treated of with in the an ProNeura subcutaneous And using began prevention relapse

the Additionally, agonist the feasibility areas type and evaluation currently with marketed the are opioid continuing studies chronic of in we Kappa non-clinical pain and receptor with X diabetes product.

from in our reported malaria. we data prevention and long-term Lastly, non-clinical programs in the encouraging of hypothyroidism

So, while these we pursue programs resources. course on intend based get we back to work and rapidly on of track, Probuphine to priorities additional

portfolio to of at and now, can’t we formal for the product right that go remarks. the take to we the the now, looking This you’re assure strategic the and if other we us ready, brings Amy, Although considerations. are I want continued as of details Board from the into questions forward. ready to end And you management We are all all progress call options look participants. to reporting both forward value from maximizing move Titan, our

Operator

Instructions] John [Operator first question at The Vandermosten is Zacks. from

John Vandermosten

Good afternoon, everyone.

product? can of And there have few point experience getting first that a to done. sense little that Braeburn’s that other might have a helped or penetration be wondering might am a some things Just the be to had what skills get if wanted ability better. are could them Probuphine, get partner for to do thinking perhaps larger I of or I relationships you needs maybe a am deeper done get missing may to

Sunil Bhonsle

Probuphine when results right our that nitty-gritty building the the in disappointing lost now was forward. understand very Clearly, carried it momentum quarter, of momentum. not the details quarter. why was saw was see John. Thanks, second the Certainly, we there And momentum that is to focus third to for

a Now, of learnt since only this we it’s been few days progress. have

out started are And understand in issues. with so, talking we have have digging, clinicians field to started the the we what

of how going to We course Braeburn and to few see with it, a for days. understand spoken this continue they is have

really benefits commitment what to how is look assuring that’s That that answers the from and are understand progress am with -- everyone that getting that do. including goal, and we come specific except in correct correct our but details Probuphine on attempting the seeing and I are really track. getting strategies you sure up we on. will we to give involved provide I to So, you this the now best to cannot Braeburn, here will forward this

John Vandermosten

And Mike up, change it. maybe little changed I the June, there there that has a or approach time something part a every in of if until if he and new wondering wondering strategy slowdown took I back over be might is is over. was was the maybe as and CEO strategy, in takes

Sunil Bhonsle

conservations had mean, Probuphine Mike it’s he commitment And previously. just he had John, to came strong. intended their Mike I was and felt support when that with product certainly clearly our in, as been to it

currently the they marketing. Of only course, are it’s product

Our that periodic, they dialogue is support continue Braeburn, always with which they indicated Probuphine. to

sense, they So, that can have Clearly, indicated. all momentum same that’s that point out what in lost. at time, that’s the was the I

out why the and how we want will. parts we to find that’s So, key and

John Vandermosten

it with agreement the maintain licensing once they to the license met, -- do it? Braeburn, and whatever then, they have be And with or minimums and there it, have to want they that they are have can certain Okay.

Sunil Bhonsle

support have they licensing It similar that The to minimums in product and does products does require other the them not it. agreement would. market to actively

things some it minimum. So, but has to not specific

that’s agreements the typical products, new how for are it is. licensing and these So, of

John Vandermosten

Canada in yet? Okay. there I that any I sublicense tonight, that know then, they Canada, sales been And Have believe.

Sunil Bhonsle

that believe mid next is Canada. date so not next or has the -- in yet. being recall It what for year, Canada approved seems in approval to year I sometime I it’s in

John Vandermosten

just R&D question the then, And is last Okay. expense. on

we’ve it’s we As quarter on the I development and and little -- with come continue to the through continued should up expect a programs, fourth guess year? level similar next bit, into

Sunil Bhonsle

third ropinirole that of some of the but included To filing some did of the with the the expenses MAA the the quarter we start-up study, also extent, November. in beginning parts of associated just

the of well potentially see So, we of from in conscious course, what took are preparation very extra We, position some as revenues now as we Probuphine. may are expenses. and things these of cash

of And part, clinical to within levels. in we we to expenses ongoing sure other things look is keep will we our for pursue. within mind will So, with stay intend contain ropinirole, to the Key manageable which course, we make study our programs budget.

I the expect than research expense by to the third a fourth So, quarter development probably and not quarter, would little a but lot. be less

John Vandermosten

Okay. Thank you, Sunil.

Sunil Bhonsle

Thank John. much. very you Sure,

Operator

question of Scott next The is Henry from Capital. Roth

Scott Henry

Thank afternoon. and good you

Sunil Bhonsle

Hey, in. Scott. could join you Glad

Scott Henry

Certainly.

general kind you As try from not happening Is you’re there with to the interesting? -- what a to what’s that you have a of feedback it’s of getting more get you is that sense and of getting reimbursement feedback landscape any it kind just received find execution or Probuphine, the survey of the issue demand physicians? of

Sunil Bhonsle

we out certainly, clinicians a in the of field. handful have with mean, I spoken

such -- large a not We haven’t group yet.

they We are when get treated do that’s a like patients continuing what they have who that What product, that they them doing to that it, indicated favorable is response. this. are have this do they about indicated, talk and they benefit and would we patients to believe this see

the goes when this positive weeks us give enthusiasm few small is to They time good. examples standpoint, switch approvals. patients that they takes the patient’s treatment to it physicians the maintaining feedback that not few -- months. simple from is the the so length it good least And frustrates it’s to numbers, from where long. to very of is takes in get So, at about What it

that and also to that the be talk And systems, physicians How should to addressed. best frustrations will so, the addressed these with about. do clearly are insurance and this the has address be

Scott Henry

If monetization products. just regards the I could pipeline to task of question. another some With of

you you obviously, would expect? know just think for could or don’t six any of could something rights, you So, monetize I mean, you table the certain, do color what the ex-U.S. next provide? in but sort you months time

Sunil Bhonsle

pursuing road. Sure. and in a things I is for a It potential the acceptance, progress along over come obviously that for approval establishing certainly Clearly, period major and in that a submitting in Europe been Probuphine of is and the months starts that six ticking these MAA next in down we that hope mean, the that clock the all we terms place. milestone. the partnership have --

we we So, that know the And that that certainly that, value, doing with are something potential treating we and Opiant eager that added half result are pursuing certainly pursuing a opioid of Pharmaceuticals the will I the antagonist with early that in is for is be And a implant program both and and results that that which interested the keen in evaluation next can. successful Opiant collaborating has disorder. into lead the available as commercial will technical we as very in Outside are side and rapidly assessment as can from assessment value Titan. early hope first be a well substantial to of year. shows you

other we NIH So, ones and WRAIR, can certainly program with that on, Opiant look look be avenues collaboration for Reed the others. government. are provide the available, And for going and we meaningful. the obviously the at And funding we what would including if and from will that the early that’s those say very for Walter have

Operator

John question next The Zacks. Vandermosten from at is

John Vandermosten

just just a or it focus all, get Is to way that partner eager along? any programs might more maybe Opiant the it has there because I TX had ropinirole at the collaboration lot follow-up. is push of or ahead

Sunil Bhonsle

made is a by that timely up of speed a epidemic can And tremendously. program has very certainly that, NIH, opioid is available something -- now. like for lot it the to if certainly potential program. funding That’s crisis right the there It it

a case. meaningful well way that medical by as So, community the hope our program looked But, it’s is at and NIH. that be the as that will it’s

John Vandermosten

Okay. Thank you.

Sunil Bhonsle

Sure.

Operator

This concludes our session. question-and-answer

back conference for over remarks. to to Now, the I’d like Bhonsle turn closing

Sunil Bhonsle

are it’s participating not coming I to track. but on us, easy this at accomplish know, we you, we trust an times, in quarter Amy. trying back lot you during Thank for one this get attempt call to and will today. a Probuphine everyone Thank

as As always, provide we we we will forward. updates move appreciate your periodic ongoing support and

So, Have good day. everyone. thanks a

Operator

This is you attending Thank concluded. for conference now presentation. today’s

disconnect. may now You

Titan Pharmaceuticals (TTNP) 9 Nov 172017 Q3 Earnings call transcript