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OSMT Osmotica Pharmaceuticals

Participants
Lisa Wilson IR
Brian Markison Chairman, President & CEO
James Schaub Executive VP & COO
Andrew Einhorn CFO
David Jacobs Head of Clinical Development and Medical Affairs
David Steinberg Jefferies
David Maris Wells Fargo
Dan Busby RBC Capital Markets
Emily Field Barclays
Call transcript
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Operator

Good day, ladies and gentlemen, and welcome to the Osmotica 2018 Business Update Call. At this time all participants are in a listen-only mode. [Operator Instructions] As a reminder, today's conference may be recorded. I'd now like to introduce your host for today's conference, Lisa Wilson, Investor Relations for Osmotica Pharmaceuticals. Ma'am, please go ahead.

Lisa Wilson

Liz. you, Thank Pharmaceuticals Update Osmotica and Year Full Welcome Fourth Business Call. XXXX to Quarter Lisa for This Investor Wilson, is Relations Osmotica. Financial JD With me Brian and Officer, Officer, Chief Osmotica's Einhorn. Chief Schaub; on today's Markison; call Chief are Officer, Andrew Executive Operating press This detailing for full ended financial and XXXX. release December afternoon, months issued XX, X results company year the a the Osmotica press the Investors through release be can accessed and This of a website the call osmotica.com. webcast of this at section

any call. afternoon's available the or not and future from that made those uncertainties, release may future differ would in our in those belief, the involve as Reform shortly like future to to are or defined conference we as that on performance completion events of statements press and Osmotica Before forward-looking materially projected law. started, call telephone risks intent except available disclaims will with statements this statements Litigation any everyone considered as Act. Securities today's filings may get I guarantees expectation, forward-looking by These remind projection, intent Actual and the statements express update a A to information the forecast, forward-looking Such be company's are results anticipation Osmotica's today and noted performance. forward-looking statements. required including these this of specifically by be SEC. management and of Private obligation forward-looking on based replay statements, regarding after

be today's release. You'll year available osmotica.com. find The website, will for our archived the X dial-in webcast on press information in

and Markison. I so to Brian then, may related webcast, like recent the or listening to be would XX, have made to XXXX. this And please Since For replay Osmotica to the that, benefit with may press March who releases call the held is on Osmotica's of archived announcements most the CEO, turn and over recorded SEC those the filings. call topics company's discussed, reference

Brian Markison

the and for in Osmotica. This XXXX, year you to IPO the meaningful portfolio branded pleased report successfully financially. We quarter. our joining the our call. driving for thank year was that fourth significant a afternoon, strong completed had in pipeline. made advancing progress company in the Good and We by I'm marked past traction

transformation We prescriptions, highlighted in and to early of our approval towards in Osmolex a continued the and growth gain are launch the monthly business, extended-release, which by with specialty-branded encouraging XXXX, solid launch well. M-XX as early traction trends where of continues

a in study Clinical franchise, and CGIC, continued of muscular per multiple to Divigel, for trial for CGIC sales Study of in a documented top both milligrams XX second demonstrate and TNmAS, were objective placebo, in category. treatment results completion measure the as is subjective, and from superiority in sclerosis milligrams Change, change from which Today, of did growing spasticity. from of day. of coprimary arbaclofen XX measured arbaclofen Total a baseline multicenter, measures day patients. we placebo assessment global Arbaclofen TNmAS patient CGIC. the in also and The are spasticity especially to is the efficacy baseline randomized, was women's share not change This a We highly line endpoints. treatment in this Impression of well-being, generalized modified maintain Global the more preliminary through XX multiple The assessed or was coprimary by XXXX, arbaclofen of Phase for study The health muscular Scale. with assessed Numeric study of Ashworth double-blind, clinical day the our and also strong placebo-controlled limb competitive the care of patients the sclerosis any III spasticity either per reporting received or

measured by review, for the it CGIC as improvement in to demonstrated significant XX-milligram both of statistically Upon milligram improvement and XX a the However, the the relative failed that doses by preliminary was TNmAS demonstrated appears spasticity recognize placebo arbaclofen. to TNmAS.

results and a Though to appear strengths, between signal milligram TNmAS a X relationship efficacy However, the day the from identify XX-milligram both values XX groups CGIC indicated with improved stronger measured the the dose-response baseline. dose also treatment as by per Preliminary exhibiting of does of the tolerability results, scale. arms, reported somnolence XX-milligram had in X.X% the compared to safety X.X% respectively, the the a for and a and placebo study, with was treatment higher XX.X% discontinuation the incidence notably previously rate in most profile for line XX arm. treatment

associated most of with events reported baclofen frequently dose-limiting is adverse today. Somnolence treatment the and one

updating analysis of we is and is work that ongoing, Our you the complete. full to data once look forward

may While the towards meaningful benefit for line to the patients mixed, believe efficacy by time treatment extend positive our XXXX. offers TNmAS efficacy submission we result schedule. announced enrollment results build signal NDA, RVL-XXXX, the arbaclofen on an of upon, completed endpoint identified this continue second spasticity and what pivotal our suffer profile is on a RevitaLid, to have intend III although we we the that Phase and previously share plan far, to to spasticity. of a of Based With results study thus of line seen from now the are we or in trial past have our top who

blinded the data appear the expectations. is of second first line the trial And high results translates thus Phase our with we that a complete, blinded into which for only safety I'd trial, first. the trial of to study even identical to second of and have the similar elements though data in far, highlight confidence. all degree program the the to are like III in Our pivotal is

financial following take the our to we'll comments, to that, questions. Einhorn, Andy. M-XX JD's commercial happy to Osmolex. Andrew? then to remarks, call Chief With some highlights call I'll Now company's Andrew after And with After which, be Schaub, company's and your JD speak closing turn over the the of CFO, our the results. over Officer, turn to to Operating will like review I'd some

Andrew Einhorn

IPO. fourth was million venlafaxine extended-release XXXX the Brian. primarily decrease higher methylphenidate quarter a $XX.X associated which expenses were field fourth tablets, SG&A quarter force million, The on ER customer offset you, in quarter fourth and to $XX.X the million of the partially Thank in XXXX. million to impacted compared in compared compared increased sales gross disputed XXXX $XX to XXXX the Osmolex by R&D to pricing the company's extended-release fourth with of in lower million reflects XXXX. decrease expansion an XXXX. in we during by XXXX, of million due hydrochloride was resolution of quarter costs This This launch Total quarter sales $XX.X an favorably revenues with for of as tablets XXXX. of to of increase sales In during of the net wholesale RevitaLid, of Divigel. the the quarter expenses of also deductions assets our sales $XX.X XXXX, fourth and taken fourth $XX.X in reflects to million the quarter Inc. associated decreased expense. the accounted $XX.X R&D which the acquired of for of fourth expenses late of

and RevitaLid, year headcount. of to clinical fourth costs Excluding R&D higher quarter This increased prior period. the additional million arbaclofen $X.X during expenses trial RVL-XXXX, reflects XXXX ER the for compared the acquisition with together of

for to the refinancing fourth million a to decrease intangible was of the XXXX $X.X we compared in of in from expense in of the nonoperating a impairment million in adjusted was due debt of quarter fourth XXXX. quarter fourth and quarter fourth of compared expenses charges quarter prepayment XXXX. $XXX.X quarter $XX.X to fourth the XXXX was fourth quarter that of of Net in lower million decreased resulted fourth XXXX completed $XX.X the in The of interest fourth during to fourth to million for transaction quarter the December million of $XX.X million Adjusted quarter of income million compared to XXXX. $X.X Other EBITDA of million no the loss $XX XXXX. of asset net of $XX compared recognized XXXX, XXXX. Additionally, of EBITDA quarter the the during charges XXXX of

by to to press M-XX, loss, end and due million to adjusted Full of increased XXXX. our to launched net XXXX. $XXX.X incurred are IPO. $XX.X Osmolex for $XX.X XXXX at hydrochloride Selling, year For related was was and in in which primarily a revenues ER, the increased or reconciliation the to the to of product follows. income This XXXX approved in Research XXXX see results Total million launches administrative of development $XX second to to from compared reflects in expenses expenses EBITDA and $XX.X please ER million which general launched Net in as XXXX. XXXX, million of in methylphenidate in and to XXXX in increased sales financial tablets force release. tables and sales additional XXXX, compared sales million in and increase ER quarter XXXX compared expenses $XXX.X company's increased in million in the costs XXXX, product to quarter third venlafaxine to $XXX.X the $XXX.X compared of XXXX. M-XX million and the offset million marketing lower

and Inc., RVL-XXXX. of Excluding the arbaclofen clinical costs XXXX the million research development and trial expenses acquisition of $XX.X in largely RevitaLid, to increased due

to loss of were the in technology compared in For to the $XX.X $XX.X impairment $XX.X million XXXX. XXXX expenses of $XXX.X prepayment and to XXXX of net development XXXX. XXXX to XXXX. $XX.X write-downs was quarter in debt with at Adjusted borrowing asset assets. the debt million intangible the Net million associated refinancing, and EBITDA end and nonoperating compared $XX other million in-process to adjusted XXXX charges in of fourth Other EBITDA XXXX, respectively, goodwill, XXXX developed million was which $XXX.X reflecting of XXXX assets and completed lower research due in loss million compared and $XX.X of in decreased million, costs was in million

of release. of net end the the reconciliation our to please adjusted a press tables For loss, see at EBITDA

financing As Osmotica its available equivalents credit and $XXX.X $XX of borrowing facility. net million costs. of capacity of and December million XX, debt, in deferred cash company $XX.X million unused had had of under also revolving cash The XXXX,

walk JD, the our like recent Now to I us product would turn who over through call launches. to will

James Schaub

women's Thanks, progress by of M-XX evolution marked Divigel. continued launch from led of the ER portfolio, business, our the Osmolex highlighted and our care branded health well Andy. in significant XXXX as growth as by

areas such strategic and a we field patient portfolio made our Additionally, marketing. as access, across investments sales growing brands key in of number promoted support of of

We remain on specialty Osmolex unique we to solid with Parkinson's brand the across for recent have delivering excited patients of lot launch, launches begin now for as and adult of initiated our will drug-induced amantadine specific M-XX, recent our with I portfolio. walk brand about January. some with to regarding growth turn promotion more aged reactions. ER, extended-release our for promoted execution XXXX attention XX updates ER, a in methylphenidate we disease strength to ADHD patients be focused our sales and I'll which and XX our daily and field extended-release Osmolex once most through extrapyramidal

early we launch to folks product into some around I Before highlights, would of briefly opportunity get reorient the and strategy. the like

Osmolex adult We a of to and fourth Parkinson's recapping of value team initial option XXXX, represents involuntary creates for expect a feel ER during the which neuropsych patients ensuring affordability. meaningful completed and have caused we be extrapyramidal Osmolex training patient launch the path point spectrum the medications. diagnosed initiatives $XXX price a reactions, Quickly sales we of are proposition with Osmolex launch a Moreover, of field movements at to by month, access readiness broad to specialty the a a we product drug-induced and priced the robust straightforward certain ER onboarding ER. and coverage, disease quarter

We shipping went began in Osmolex, live and also services with channel comprehensive full center patient affordability, partners first product anticipation and January support Access to XXXX. of and to our launch pharmacy in our parallel, access our completed in

Medicare Lastly, increased Part across contributed to engagement plans. product payer and availability commercial also D

a to launch Now more recent update. turning

are trends, by progress customer early our ER. feedback for the with encouraged We payer Osmolex discussions and

early is X of where promotion. weeks progress the first February, it days, the While very of following still approximately through end the data reflect points

patients of we anticipate visibility the we prescribers trends, year, beginning Access for XXXX prescription TRx a Osmolex currently, to early most ER and some XXX Through afford our favorably broad beyond. spectrum Osmolex, including around earnings trends provide throughout we seen color and as early As this approximately actual movement enrolling our flexibility, reminder, The viewed the neurology, but unique features been key not disorder well XX adoption quarterly of channel across seeing dosing additional adoption this psychiatry the received target physician does regular being solid have by we indication. report with the via February strategy and by audience, benefits as have on. indication price importantly, specialists of with specialties, broad supported increased and are label product of

spanning further support acceptance thus benefits Access services Osmolex, assistance verification, from reimbursement and through support, patient program enhanced and have product patients Our the receptivity investigation, physicians support, far. ancillary patient and

around also ER to initiate to are by on sampled present ability and for of sample added the are decisions Osmolex providing regular appropriate We encouraged configuration, X patients at physicians a X our the monthly spot the receiving patient while enthusiasm therapy offers which strengths as bridge and the titration dosage coverage prescription. for formal optionality their

coverage with front, and through continue Medicare commercial and buyer and payer we the D seeing our exception On we authorization early formulary good discussions overall are plans. Part contract while

the expanding over commercial in Osmolex July plans months make and plans come, although year. to of decisions several of complete would coverage throughout as with occurring early More as formulary ER Part expect Medicare specifically, to Osmolex XXXX. reviews add could providers forward, periodically we D coverage to XXXX, predominantly January this Looking these ER we anticipate

disciplined remain contracting our will believe ER Osmolex appropriate We meaningful in option the provides for approach populations. strategy patient a and and

tablet methylphenidate, to team. and XX M-XX, in our broader in extended-release treatment XX. M-XX or was patients of for Turning of sales launched neuroscience our once-daily aged to XXXX through ADHD now the April promoted is adult XX-milligram

further and of We large resulting unique total first to of requirements note, to strength commercial authorization reset year, expect view supported any prior This and Of new experienced XXXX. with prior growth, single-dose date as of over we are months of move to two the XXXX as the we associated the throughout deductibles co-pays growth X,XXX had and pharmacy solid $XX the prescriptions XX% prescribers benefit the seeing commercial approximately In of continue pharmacies monthly XXXX, less as out-of-pocket the prescription. we this solid in dispensed of that product over coverage insured and XX-milligram positioned an year. foundation expanding provider assistance and a well patients opportunity. only are co-pay year-end. trends remainder XXXX stocking payer plan continue Strong over initial the to X,XXX growth market M-XX into despite through a and or tablet these at has

Now like would back for to to the I turn call Brian closing remarks.

Brian Markison

made progress that we Q&A, proud thus numerous XXXX. in before I would encouraged to like the Thanks, across organization we and of JD. to far And the head XXXX are state in accomplishments the entire by

our As timely late-stage evidenced generic the transformation a our from and base a ongoing support well the by a in this to Marietta its branded business. ER and is launch of pipeline, January, diversified nonpromoted facility January Osmolex of our successful derived FDA revenue to from progress Osmotica inspection products of positioned past

on positions augmenting we built. broad us for near external for exploring over sheet future. with a balance platform business progress opportunities, market to the the look your call any Our have update in our cash and we Thank also turn I'd to time like And further to to this development flow that, continuing robust the operator and afternoon, list to organic you continue questions. of forward the the

Operator

first [Operator David comes question Instructions] from with line Steinberg the Our Jefferies. of

line is Your open. now

David Steinberg

Thanks I questions. had much. very two

going but did First, filing And give path to the tablets? could forward by with the improvement Concerta then Or study as on measured on your obviously my do significant hand, the CGIC there's score. a data? with you more or to around statistically think scale, spasticity I as the do other you're us or little extended-release rerun of superiority forward demonstrate - measured the by think color totality statistical you revolves -- question another just arbaclofen Ashworth not It have in you potential market. move generic pathway was X? you second a to given have curious, a the the

So have could you increased of dynamics at market of market and like current and there've ANA Amneal the us I both launched expense entrants in the on pricing? couple thoughts Looks February, Teva on a share impact recent actually But on Thanks. and Patriot given in launched share been generic on your to recently you new Mylan. recently. guess new of held and and these fill Concerta [ph] actually launches. entrants,

Brian Markison

Okay. answer, because to the methylphenidate first Thanks, with start question. a we'll we'll come answer and your then David. and What shorter back I it's is question do believe I'll arbaclofen the field

JD, So, about want do you talk to methyl?

James Schaub

Yeah. Good afternoon, the for David. question. Thanks

customer being of our that the months, of able component and maintain approvals So attributed with several think volume in think occurred strong with to and relationships, that the you as last the is to And business share of methylphenidate, some have an terms we've I transitions suppliers alluded particular. influx seen product. new but of I to much also BX-rated the over in

the early BX competition not transition we've and any think but I that, supplier. year creep to business as market-leading I some some we've pressure with, on seen something a the of methylphenidate slowly more, side we've pricing, move of put on it extended-release our generic that's With I back. this forced to affected think think start that, has on the to branded like volumes the increased been and volume in market begin had market, also seen and status

Brian Markison

Okay.

to data we Clinical Jacobs, our arbaclofen Tina like deepened me with there, to in. also of trial deVries, And the with of that point I'd that's Affairs. question, analysis the Dr. the the out and Medical and on is Head and R&D, our So Development the on Head of coming call, Dr. obviously,

was the pretty XX dose-response the one, this highlight, mentioned, The relationship that trial. about as clear, preliminary. XX particular But between path in because, and it's almost forward the the The striking signal has we effects dizziness. molecule arbaclofen, from So symptoms, strongly feel very therapy for I want favorable to you Ashworth picture quite very with CNS-mediated this our seem thesis with urinary today also quite somnolence, classic baclofen of beginning. the be very evident. which was favorable that affect appears The tolerability been molecule, side number to

Impression well. we to The that Global baseline, format has improvement quite of from we important product and other as that's the I weren't I think an saw Clinical out platform. an Change, CGIC, thing while extended-release on to is point the out want Osmodex of placebo, the superior The certainly

to anecdotes is before sleeping we We being exposed have database spasticity this where baclofen of largest prior that's data us that the interesting couldn't of And even the quite trials the this forward. patients single in and of rich night we to have the to therapy. program, after afford with other numerous move through part in believe going it's it's they

you'd can is but... will ahead, be and to have I for that, another like we unmistakable. a what we and like I to trial, say So but feel that we we comment sure David, feel covered signal run if Ashworth on little bit strong think clinical won't was I've - very a the And pathway required we it,

David Jacobs

I covered think No, it, you Brian.

Just for and signal good dose-response we XX Ashworth to with milligrams the a dose. the the have milligrams recapitulate, XX

spasticity the MS mentioned, in most And as Scale is Brian this know, is assessment trial. spasticity largest, sclerosis. for As Ashworth robust you the definitive the all multiple

this of we arbaclofen think we pretty efficacy have confident a where feel very in clear I So signal patient population. with

Brian Markison

Okay.

next move Let’s the question. to

Operator

question from with comes Our David line Wells Fargo. of next Maris

line is Your open. now

David Maris

afternoon. Good

Just a few questions.

any color a is us bolt-on come as larger sheet but a of you're other to of of And and sheet other good Can you robust only not-too-extended mentioned business good you deals the should adjusted from larger what deals bolt-on balance it Thank is or strategy? more pipeline. standpoint, Osmotica thought a That along? look We've looking Are a pipeline-type a thinking business Or cash always do deals? Is things operations. also you they on just at allow deals. blank it you'll that development from bit opportunistically there about? as at part you give EBITDA, deals? So you. with

Brian Markison

our excited are certainly now, Well, footprint mostly We're that to to right team looking which robust now. shapes current it women's take RVL, and be, a the at is set that be then will to David. when like frankly, neuro, we're and market our care we health sizes. development in all of right into quite thanks, business with open We'd Yeah, gets able approved. opportunities

bolt-ons R&D at X major down. looking we're capacity where the our shop programs have in as right we So now wind

capability is in that flexible, out We proud today. have quite team the that's of the we're commercial scale and very and field

if along, of stock come were terms the scale, in don't would want use it. right our to take open. we're so proposition but And a certainly at We look hard we right now, to

David Maris

rate Great. that and the for And the if year year expectation on as that, XXXX, the ongoing big R&D we of follow-up spend about was think last a being given thought studies just spending because a maybe may continue just will on be or moderating may year that was than last higher this year, additional a consider should do you we it work that arbaclofen? slightly it at similar

Brian Markison

I do guidance, we We're lower will be last even year. giving additional it than if be year not will think lower. this but definitely work on arbaclofen, it

David Maris

Great. Thank you.

Brian Markison

right. All

please. question Next

Operator

of Randall Our Markets. Capital the line next from comes Stanicky with question RBC

is line now open. Your

Dan Busby

Dan on as well. Randall. Thanks. This Couple Busby of questions is for

For but to rather terms but forward? ramp a I do reason And believe you little the slow for do you trend sales what's expect expect point of for about Do product sales to date, think accelerate continue it you to that have the could Or going been future? M-XX uptake foreseeable that And in has at that there? talked the some steady. future? specifically, outlook in a what you the bit,

Brian Markison

Thanks, month, seeing in a the pretty so ramp molecule We're Yeah. to we're about Dan. encouraged and steady growth fairly month that.

to want some will at quicker point, ramp some it to it deeply add little in a seated that? as JD, do gets even marketplace, think more the but, color I you

James Schaub

Yeah.

the a in offices for therapy. in expect think we the of these XX that first that's to their we we XX-milligram go. and now, appropriate continue acceleration terms and fact over think growth and of And on stable well. particular, that stable X ability in months volume in accelerate have opportunity, I not that of field XX, pace, is I the the as is but or a patients are some the doses patients the the to be product seen believe at configuration we expect daily, to And that launch XX continue to beyond to of other that and we targets just as out XX high some methylphenidate So continue would a by of there grow identify function of where XX this milligrams

this Now that do the ongoing a what does look like? relationships means that again, growth few sensitivities the you going years as and a the a clip. stick product molecule the doubling product comfort to back within of product to even the no move hockey market of the and there complete By of and contribute is that, will I this of that level, from acceleration trajectory curve, a think and handful utilization same now, are but learning’s patient

Dan Busby

helpful. question Andy. That's And Okay. then for just one

programs tell us development million you just For can last impairment products asset relates to? which charge or $XX quarter, the that intangible

Andrew Einhorn

million about to Sure. we The $XX million quarter took. includes the a in that last $XX related charge impairment goodwill

We development discontinue partnered to product. to generic us. on came not of also product discontinued made commercialize that that that the acquired that previous in acquisition working had product also were have and been We product we we that a back that and a election a

Dan Busby

Thanks. it. Got Okay.

Brian Markison

Okay.

Next question please.

Operator

Field Emily of line the from comes question Barclays. next with Our

Your line now is open.

Emily Field

saw the the extended difference? was curve believe from from clear wasn't and approval that in through understand doses? Yeah, more caused seek have is that are separation there that Ashworth CGIC, just basis? somewhat that then quarter analysis? time I a of XXXX just is And run far if you. then David's kind on if seems R&D study what that any that that Scale would have to continue SG&A - XXXX it you also, I was into I needing time was in curious the results separation. the to much endpoint whereas Thank a anything secondary for regards both with with there cause the And may was in just the the flipped, the you reason placebo with not Is fourth run And I thus on rate, believe quarterly intuitive XXXX the almost arbaclofen, just we a there but rate safety looks to results - just of study, there on financials, we'll Hi. line similar the it go question to for like in

Brian Markison

questions. Well, that Are in the U.K.? was bunch a Emily, you of

Emily Field

Yes.

Brian Markison

sorry. see the for first, If so I to Oh, I apologize. you're screen you the I'm I get to can't would knew queue. on, try I

Emily Field

It's okay.

Brian Markison

Okay.

to So take of or be to bit. little XXXX, fourth the SG&A quarter would seem a give similar

guidance, giving not we're again, but... So

Andrew Einhorn

sales Osmolex. We've now force put in place for the

We have public that company runway other be rate. costs run We similar probably a that, and - we would marketing anticipate programs. don't - anticipate very

Brian Markison

the CGIC meet placebo. arbaclofen XXXX, both in trial All statistical and, that versus on arbaclofen, right. not did CGIC And endpoints, on then coprimary met the and Ashworth, the baclofen significance in fact,

similar is Here, - the where trial, effect, XX-milligram, it. even to And what that a effect, with we showing study they're a hierarchy efficacy, very both new Ashworth placebo, we out as both have for coming very XXXX, study, the all commonly CGIC a set what's with we're the described patients meeting have in similar prespecified in seeing in if we been XX-milligram, did I want if the help such anything, question? Or correct? on a a that. miss the difficult do, all And to something trial Emily, think, questions your them. disease of on particularly to to you hope you before David, being the arbaclofen - on going really did and get to I I But often attention elaborate that's respond them the paid in that's

Emily Field

analysis through you would cause I'm incremental had No. there believe to no follow-ups go approval that assuming needing was to And just, the then line both the any the don't only extended you'll question – of need And studies. I you that doses. then that seek just that just given is the time signals secondary other were endpoint not

Brian Markison

in I latter they Scale, so and by they did a preliminary higher increase awash we and on data, secondary I haven't question, the gotten so we're improve did in XX-milligram. the an XX-milligram. that. the dropout benefit a to really baseline on part And going in But on encouraged their endpoints, again, own both CGIC, on we're adverse we we're that the both, you think rate on far the think the relative change we're the the We we And would events K yet. as the all to reason for subjects XX-milligram have believe go because that And for is completed, significant No, materially. CGIC doses. value we disclosing deadline, have we're on the that of was expect, had don't of preliminary going review for to the the did see, upon going Ashworth that and early

So everybody we would know as decided soon we that we as let could.

want So bit David, to little to do a you add that?

David Jacobs

wanted dose. have with And we're to to adverse dose one add that that not in qualitative insofar XX-milligram XX-milligram any new new just regards the we point we didn't any was the with insofar studied XXXX see events the we're I study. more I Yeah, to didn't seeing with the that - or think assured concerns regards

nothing along So lines. those prohibitive

Emily Field

very Thank Okay. you much.

Operator

the your queue I'm showing and question-and-answer session. Ladies you And this questions thank program. for And conference. in today's at that time. today's in no This participation concludes further will gentlemen, conclude

a day. You have may great now disconnect. Everyone,