SEEL - Earnings call transcript Q3 2017 | Seelos Therapeutics, Inc.

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Operator

Greetings, and welcome to the Apricus Biosciences Third Quarter 2017 Financial Results and Corporate Update Teleconference and Webcast. [Operator Instructions].

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Matt Beck. Please go ahead.

Matthew Beck

you us thank and afternoon, for today. joining Good Group, for Apricus Matt with Relations Trout The I'm Biosciences. Investor Finance, me With today Deck. of Pascoe; from Executive Kelly Chief Officer, Apricus Rich Executive and is Director

will today's the and review the the will in and remainder provide During XXXX quarter financial Rich a review results. early company's third roadmap of corporate the quarter briefly and XXXX year-to-date brief review of third progress the for Kelly call, XXXX.

performance which I'd the like the earlier will Rich company's objectives, open on the Pascoe. XX, to financial be also may information documents XX-K including Private materially. up the statements for on on other provisions and affect for www.apricusbio.com. and on filed approval current questions. and today's report call, as today filings results regulatory future Act, XX-Q, release pipeline. discussions that to conference over line the with the future We that of Reform statements remind report the outcomes our company's will earlier predictions that and and Exchange quarterly annual third certain forward-looking now the the and the for wire Please of conference can process RayVa; the today to regarding crossed events additional Such can and business. call Apricus' for the uses management discussed or company's Form Commission, cash results expectations call was Apricus' found company, statements then everyone could products plans based company's relating such is regarding actual Form safe the September today's of risks I are development be be differ on Security the ended Rich? on XXXX, will reserves Litigation to and timing certain the quarter refer during website. most covered turn at Securities and recent of development U.S. of for expected These under press including harbor out-licensing these Vitaros; business Apricus' financial also accessed website making

Richard Pascoe

for and Matt. drug In with the operating new Food quarter Drug you, NDA, Vitaros continued Good sheet to a you afternoon, outlook financial in objectives this XXXX. the of the on all corporate through expected current end fund today. U.S. thank year, us of the call on joining as for resubmission improving execute by third and our key filing Thank the Administration resulting and our to application our balance plan we

regarding As acceptance the FDA our response additional PDUFA addressed risk-benefit we an and basis remain an complete confident further Vitaros on the continued have and safety support interact of a the efficacy in of review, we February our goal resubmission that data. profile is team and the deficiencies of NDA at and as-needed their the the members with the our analysis with effort that strengthen review and we XX, reminder, FDA date to to our confirmed NDA XXXX. submission, receipt acknowledged have Since

U.S. continued have we we further taken prepare date, steps approval commercialization. for Importantly, To the secure the to look Vitaros to Vitaros decision Vitaros to chain. beyond supply

payers We broader and research to quantitative effort ED have opportunity category. patients, the understand qualitative research with completed an and Vitaros extensive both include U.S. the to market better and providers

Allergan believe U.S. doing the successful as we are have we approval we in following distribution We approval. will to finalizing dialogue as that upon patients, whether - the launch we the On on positioning have and this maintaining Allergan well are that strategies revenue to in another that targeting to support and pricing enable note, products work, with for Vitaros enabled following begun Vitaros further We make Vitaros physician a informed and U.S. Allergan will be an such and United to to effort the enable further in in we maximize access preparatory believe the commercialize decision decision, its to to its regarding or approval. Vitaros aid in commercialization successfully Vitaros potential for an productive the party on commercial States work

net Allergan the the XXXX in licensed to option is product $XX If Allergan upon free and commercialize in a approval. a reminder, Apricus commercialize to a rights they the the on royalty pay and royalty the would Apricus Vitaros, partner a double-digit to have to million asset the elect retains not sales. payment commercialize milestones does double-digit Vitaros up agreed net or the sales. in If As to owe product commercialize additional U.S. in optioned and Allergan million Apricus to Allergan on U.S. $X to Vitaros U.S., upfront itself

alternative there While which of we options commercial continue interested commercial believe pursue that for Vitaros, Allergan highly is are will for Vitaros, to a partner parties. partner we attractive multiple

to remainder commercial a manage quarter Vitaros our the continuing securing for of XXXX to NDA, corporate resources. like our year, With will to review partner to over results. we the for launch, focus preparing development call the on with For Vitaros diligently financial turn Kelly? third the regarding working that, this and I'd FDA RayVa Kelly

Kelly Deck

NDA rights of and during was Net September share other XXXX. XX, Net or for per million compared as a to the sale the well of XXXX quarter G&A Ferring. the compared income of $X.X loss to to or the $X.X due recorded a share loss million the third loss the for primarily third third XXXX, million $X.X XX, Thank X during $X.X regulatory quarter ended XXXX, of of of X of and Vitaros net $X.XX September per Vitaros gain quarter income per commercial ended upon net made assets per to you, months quarter or $XX.X a $X.X the for income loss or of $X.XX million ended $X.XX a to for XXXX. ex-U.S. due the the milestone million for activities our share September payment as was loss loss primarily was the to Rich. expenses. was Net of Vitaros Net $X.XX loss XX, Allergan of months XXXX, share of million resubmission

activity presented, has all our presented For a financial ex-U.S. to Vitaros periods discontinued business related statement been operation.

remarks. As to of XXXX. over to XX, turn cash totaled $X.X for the December million will of call his September $X.X XXXX, XX, the now million company's as back compared closing Rich? Rich I

Richard Pascoe

I this Kelly. significant the to put effort In of recognize want benefit we has you, reiterate our pipeline tremendous to team closing, the create with also our shareholders. this made entire value the higher in pivotal want call progress to and a to year as move questions. to Thank team forth to for open have be PDUFA excited third will Apricus for quarter I Operator? ground, Vitaros the our on now positive decision our anticipate we next the we lead period I'm year. up early that, to able With through

Operator

[Operator Instructions].

from H.C. Our first of Yi comes question Wainwright. Chen

Mitchell Kapoor

on FDA date Yi. This continuing question was FDA. update situation is, review set? My Mitchell any to the since there you're on interact first is that mentioned Has the you Vitaros been for the PDUFA from team the with at

Richard Pascoe

Thanks, Mitchell, and our Yi regards. give

respect in are with we to As submission. FDA basis the an dialogue with on ongoing expected, the

year. in goal for date date February made next was we've reviewed the know, PDUFA was back set It thereafter. the you approval of XX and submission shortly decision As August. accepted

the addressed further said, we've - as the for we coming and relationship overall data in As months. the qualification continue in provided we'll application review expected, date, we that Leading to concerns had decision analysis confident with of in original we the a we the response expect process, that They And we on the as up we we to strengthened the remain FDA. with issues, continue have have that of fact have complied FDA that. have the with And suggested, sort complete additional to and working I with. that dialogue course, that FDA. the certain with asked we continue expressed

positive. And been very far, so it's

Mitchell Kapoor

great. commercialization? interest expressed recent Allergan into in any And the opting has Okay,

Richard Pascoe

healthy They as relating commercial it taking help I preparatory - opt-in rights. will I their exercise product this commercialized And itself. as has they're involved do Well, that some with even a to a of make up approval Allergan as the just around this did have were you remarks, we the until transaction we know, Ferring. are And right work Allergan. the - that not prepared and ourself, have to continue the upon of decision heavily with said until Having we we year to just a though we're product to that position the we U.S., in in with ourselves the said, as reminder, my U.S. outside commercialize preapproval, noted the the not think we process earlier informed products ourself potential an precommercialization I that to expressed obligated although have previously, Allergan exchange

have And commercial that a to with of respect opportunity. the the knowledge table so, we can we bring institutional lot to

we can that approval use. FDA, for market that as else to are in in make the my think the interested effort a decision the have decision interest. that's of if Vitaros launch package, doing help put create bring best Allergan outside informed our see forth remarks, multiple market as understand forward we same we I said by a we to And relationship. someone that all and put So, that and the parties in will, And the you it format of we out, opts could after into an prepare to Allergan and itself believe that if Allergan that

facilitate positive party and/or So, and the is helps to that, commercialize a think Allergan to product. all of decision we by another

Mitchell Kapoor

update search question just Okay, here. RayVa? last the awesome. my for us on partner for you Could And

Richard Pascoe

Yes.

priority for process continues to So, be the RayVa a us.

with in are respect We to that. dialogue parties with

fair is, that say focused program. to our to respect trying impact some of table. a lot how think course, is the of we and an outcome in to partner, on the to bring that of RayVa it's RayVa primarily have that the interest Vitaros might There issues with I ex-U.S.

to down partners in outcome And conversation, may how the we'll to continue path that that may potential to RayVa, the so, of with potential approvability Vitaros RayVa weave program. we and for think and for I affect as march its our have not sort or

it's that a the in over think that I can return it's want and and period candidate, interest, way to we time. our done most RayVa a fair of that provide with the whatever do as make development longest our to think say sure benefit there's we shareholders I shareholders to

and can't should it be that our as the transaction, one And so priority. our is first shareholders focus the a we transaction our we timing good for do will that's of predict. But

Mitchell Kapoor

times. exciting It's Great.

Richard Pascoe

pleased had the the with FDA Yes, pleased with certainly and we're we've quarter in today. progress dialogue the the very and excited we've made with

Operator

comes question Albany next Our from of Jay SeeThruEquity.

Jay Albany

the timing in this Allergan could decision on would us update that exercise to remind you that possibly to Would the FDA whether us make or have its - after happen decide to option?

Richard Pascoe

Yes.

to has days, Allergan X-X So, XX to post-approval opt in. days, up

Our work goal, soon so opt-in decision course, continue to Allergan to side. as with their practical preapproval is that, could on of that to be as made commercialize decision

guarantee we we to any they do So, facilitate our have that decision. through approach move with to open can't provide we're efforts their own has information while that that them our with been to that, them than will have - and generating be quicker much we as

So, that decision or hope and that longest itself. can days. have would they is approval period the make closer their to they We of XX time sooner decision expect

Richard Pascoe

the all good of out here operator, XXXX of We to a call I you So, listen thank the and disconnect. And now things to forward we'll those with in company. come XXXX. their that, call that, some may that continued for in and close with on support today. the our will look to finish shareholders Again, later strong want

Operator

does program, thank Ladies Everyone, have you and a conference. may This in gentlemen, great conclude all today's and you for day. participating disconnect. the

Seelos Therapeutics (SEELQ) 5 Nov 172017 Q3 Earnings call transcript