REPH - Earnings call transcript Q1 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to the Recro Pharma First Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Ms. Wildenradt. Natalie begin. may you Ma'am

Natalie Wildenradt

today morning, Mike and conference financial us today's John Vice Lake, am for This Chief Executive President Executive Harlow, Officer; Chief thank to discuss Operating you Ryan joined I call and XXXX Financial Natalie joining Gerri Recro's Henwood, is and Officer; on Chief Wildenradt, Good Commercial. by Celano, first results. and President, quarter Officer;

questions, by website today we the Gerri, Ryan which News we be John, also open The Investors for release, issued detailing morning, remarks of and call our operating will recropharma.com. available. up the months three & page press financial XX, prepared the at ended for press this XXXX. will is Mike release and on our Following Earlier for March results a available

development file should, provided our risks upcoming, of Before Results meloxicam from cause comments, Factors as outlook, estimate, XX-K similar meaning. including to the with year for this the and are Securities plan, on and remarks forward-looking other regulatory X, identified or words approved, the certain performance product commercialization we which the described such of Pharma's subject be Form and XX, are and Reform forward-looking you future and we statements believe, Discussion ended on that by forecasts, to of the of Any expectations and to will, of anticipate, plan, of These statements of may Risk day is such our not for Management's our Safe on These Act today as expect, Operations remind sections risks only the of and Recro the forward-looking on results words SEC's are Annual to Private and call and Harbor and undertake other on statements may that materially and XXXX, December the Analysis may, if uncertainties various IV plan. I'll pursuant our of actual call this IV XXXX, constitute of Condition intend and differ of and new can financial risks obligation May Provision related of acceptance Report to this opportunities no forward-looking and Any Litigation uncertainties. the Financial we make in involve market meloxicam available plan begin otherwise. guarantees and future Securities statements on website. we formal the statements Exchange Commission any update make account information is information, we provide conference call, fiscal events XXXX,

of is any addition, to financial In materially. company. may results and or does differ be positions purport the may or preliminary financial operating forma information results that Actual unaudited pro provided project not

by any call IV turn no In we There would and approved Gerri agency. of approved addition, of Use meloxicam to marketing Henwood. include IV regulatory to IV be safety this is of use meloxicam been has The on an references that product. not meloxicam the will the call FDA. determined. will by investigational for investigational IV the I to been has efficacy Gerri? meloxicam, like now guarantee not over

Gerri Henwood

the across start company. the Care you We're thank strong you, all making and a us XXXX, to Acute Thank manufacturing in both Natalie, and of the divisions joining this progress morning. off for meaningful

to under COX-X severe inhibitor IV For non-opioid currently pain. once-daily the those of of review is story, Recro U.S. lead you our the new Food and preferential management Administration the with candidate product Drug to for a meloxicam, moderate

XXXX. for is May IV meloxicam XX, date Our PDUFA action

but to have We the PDUFA date. be updates FDA, they time on relative believe no from to intend

covering the our potential from to will announced property of some FDA, launch these is notifications in Orange-Book overview to portfolio. the In meloxicam one team the be prepared hear brief John Recro commercial and the a milestones months. that receipt USPTO, for call. of listable, product-by-process approved with from the expansion the key over May past of taken like valuable XXXX. XXXX, for issue would We striving by three for the innovations in We meloxicam. IV we're few patent as IV a with as provide I IV strong you remain now if patent the Our intellectual patents well achieved place to of further patents associated of have anticipate of later committed activities meloxicam expiry and protecting

III scientific challenges to procedures, IV management. quarter, across trials expected, Society the Annual Phase and posters IV II sites ASRA as pain from application in orthopedic performed we meloxicam of in important Phase the and American Surgeons and were populations posters April, meloxicam impairment. post-surgical supporting the of at pain well acute use bunionectomy patient we of major FDA. patients like meloxicam age abdominoplasty, Meeting, eight both The highlighted At symposiums, production IV drug Annual with clinical American of Orthopaedic advanced associated previously and new the Academy product moderate settings data hosted of During extremely renal discussing two certain presented the for Medicine. inspections XXrd by severe Pain Anesthesia XXXX In Meeting pre-approval including and faced the of the opioid several well-attended as drug with Regional

In assuming Viscusi, where meloxicam we journals, hosted in approval. IV Clinical published discussion Analyst Clinical Director and meloxicam New launch Acute was be Recro's York quarter, and prominent February, the and Chief Journal City, featured also NYU Dr. University; Day Pain, first an at leaders Pain Langone. pain Eugene Research, also Journal Richard Investor Reconstruction what management: of in-depth orthopedics at the Jefferson would Adult of including and Thomas Management IV commercialization in Journal thought During about peer-reviewed Iorio, Dr. three plans There papers the for strategy an two presentations by of Pain in we the of we Pharmacology. and

now first now the Ryan ongoing of our over Turning provides quarter. $XX.X XXXX, had discuss revenues a meloxicam. the to and development will call manufacturing discuss commentary, and generating to division. financial financial his After our million to will advance the Harlow the preparations commercial launch John solid highlights. I to during contract We've of IV Ryan, start turn potential of Ryan?

Ryan Lake

review issued our first Thanks, Good we the outlining everyone. Gerri. quarter of I'll Since earlier key highlights. some morning, today, our Form financial and press XX-Q a just full results, release

IV million cash, quarter increase of our the from $XX.X first to primarily the team increase products. salaries an to of due other for million expenses million primarily to XX, in the XXXX. in in had headcount, were As meloxicam, due Revenues was of were research revenue pre-commercialization the increases cash recognized $XX.X These manufacturing IV expenses quarter offset development March for for $X.X of clinical meloxicam million. a an first pipeline equivalents impact benefits increased in This of costs royalties short-term for XXXX. XXXX, XXXX, quarter the to and [ph] compared expense $XX.X trial of Recro and for of XXXX of investments modest million Research the in partners net and compared research quarter and result was increase of by adoption XXXX increase for and commercial one costs compared lower Cost expenses prior of million, and development development The in after increase of and structure The new $XX.X for rib first recognition for million were of the development increase the $X.X General standard. to $X commercial revenue of sales quarter compared the quarter administrative XXXX. first was to of year. of the of the to the costs. the of remained constant first building $X.X due expenses million its first quarter related million were $X.X and were first XXXX. $X.X compared to primarily million,

$XX and guidance, despite CDMO with in timing order existing our customer new we revenue XXXX impact believe taking unfavorable customer's patterns, million as and approximately product as our contracts, standard reaffirming of consideration experience are revenue estimations. the market will anticipated from recognition well the into generate We

our IV guidance meloxicam. to this the advance meloxicam of time. provided now revenue discuss IV and the not I'd over John? launch commercial preparations have call We to ongoing potential at turn to of John for like organizational

John Harlow

Good preparing transition the for a commercial-stage At to everyone. morning, company. are Ryan. Recro, we Thanks,

and XX past determining and leading engaged product of establishment branding, we've in team tactics the others. a our and significant launch range at activities Care segments customer commercial-stage a the of launches mapping been organization. critical the months, team. in commercialization world-class Over evaluations, core with pre-commercialization At including expertise process among has market concentrated on building the Acute We've of strong experienced

IV the dominated opioid majority know, the current may pain you IV opioid. analgesia with receive of inpatients many by the treated And of landscape As monotherapy. is acute

as a available As meloxicam therapeutic represents options. treatment acting compared meaningful currently non-opioid long differentiated to a IV agent

exposed in a who ultimately In fact, of XX% hospital opioid to opioids. first are users setting, become of X% and long-term patients, opioid-naive are

will increasing stay physicians and clear believe the discharge, institutions, accelerate place product events. IV plan ambulatory and we of by that opioids. pain, IV IV We opioid six XXX segments Care potential the economic initial meloxicam's cover which related and standpoint, the durable identifying primary date same back centers market, on And believe and and Based turn we've colorectal the approximately from and consumption, allows pillar length to opportunity economic Gerri? we've We hospitals national patients. which I'll we provides profile. a XXX will Acute dosing Gerri launch for patients approximately while discharge of has months. market And meloxicam's our both at while healthcare XX% market in pain. serve to an of reduce candidate. believe analysis, and surgeons opioid From some centers a with opportunity. us than key strategy profile surgical in approximately reduced treat now the of we believe, the of addressable procedures reducing value. more surgeons. representatives determined after perform will allow approval managing to We call Segments these into other this ambulatory orthopedic efficiently while our Given representatives in specifically to meloxicam surgeons IV to The reduction to we success. launch. GI XX to complex surgical clinical IV adverse momentum meloxicam standpoint, discuss roughly analgesic hospitals. crisis, can sales managed effectively conducted the maximizing valuable as in From we opioid XX-hour A urgency general meloxicam's believe our will alternative believe, to expand through an procedures to both briefly representative clinical approach expenses, then, awareness effectively surgeons represent of is surgeons, a identified as of profile benefit builds,

Gerri Henwood

Acute Meeting. Anesthesiologists Well, The the and These antagonize also is we acquired at suite product. provide and John. In stage but the the University is believe significant care We to this molecules, a meaningful these data solely and surgical time preclinical of We in and rapid-acting Association agents Operator? pharmacoeconomic and they data recovery. showcase preclinical presented Annual to now was XXXX, and ultra-short providing agent for to not in like of reduce unit, open meloxicam ability the reversal call the pipeline. IV to our the only product depth significant demonstrated Care Care questions. represent have Thanks, neuromuscular value is from the limited preclinical Cornell potential lead one for of these division candidate. model, one XXXX blocking to believe for acting Acute reversal post-anesthesia neuromuscular assets the blocking activity of agent the which April, not a potential molecule primate benefit our induce the in Recro, clinical rapid hospitals. to effective anesthesia future I'd

Operator

Piper comes from with Jaffray. [Operator Instructions] first question Our Amsellem David

line now is open. Your

David Amsellem

and morning. good Thanks

couple just a of So questions.

us the First, about the you're can sense just you IV Gerri, to how through on give PDUFA. meloxicam, help reimbursement landscape. process regarding pick pricing. regarding your the to companies wanted understand in brain pricing? have secondly, post-op are of effectuate us then Pacira But get Other trying a Obviously, And thinking just still space, your such we as to I thought reimbursements. on change

or thoughts terms months to on then the these your wanted or options I in And X of really out to you your to addition get to see talk Gainesville, of the over next you year customers add of ability non-opioid what just just progresses. also and unbundling regarding Thanks. of reimbursement XX the lastly, as customers new potential paradigm. capacity can expectation new So

Gerri Henwood

John to pricing meloxicam I'll I'm going to And well. IV in on the David. started as chime on thanks, and Sure, get ask then that

And and Originally, we ton between issues $XX issues, a out-patient $XXX. of So range well we've the doing as of been smaller if has of as want you the that. down the about notionally pricing as to than on both wonder to have on research that customers, a our us side, range you know, to that. been John, talking economic to in-patient work narrowed a that's side. I price talk the understanding

John Harlow

David. sure, the Yeah, Thanks for question.

day going of dose. be a $XX well Gerri effective believe approximately to we in to as ambulatory be originally as the had and And would $XX the formulary $XXX $XXX uptake, of a range surgical cost, makers, to is comprehensive as with in terms We've done which per stated, we range hospital pricing that as customer of So $XXX. some both the acquisition or work $XX access, the well to in setting. as setting, extensive decision in

the of that at range we that which stages forward get and tweaking number. a are refining specific to specific We final would in with go number, approval to

David Amsellem

If sort expecting I your something of treatment - it two may days is three the follow-up even range what's average of sneak are to that to in of day in type of is terms number assumption you that a is, smaller? or -

Gerri Henwood

So with associated at I David. to care that, settings have the think we of look

while between out-patient The that receive So one possibility of setting dose are discharge. in care, patient be assumptions one dose right long-term there the the could and of in than sometime more will interop the a now.

if the length at longer we we're side, colorectal such procedures, looking look especially, in-patient as of stay at - the surgery. On

to assumptions have three I But think one on focused looking own days. at we're our forecast two.

Michael Celano

this David, raised. in Celano. you Mike on question have is And, jump I'll the CDMO that

of all, facility, of running the relative two-thirds capacity First roughly capacity. of we're to about

capacity As capability, investment significant very you that have area. a which tableting in know, we commercial we significant made in

our to continue of reaffirm million. guidance We $XX

very later analysis as we proposal activity, some strong be into better a which feel activity, We have get in we'll year. to do position this

David Amsellem

then, that's thoughts just And landscape? Gerri, payer helpful, your and reimbursement then, Okay. on on

Gerri Henwood

non-opioid we're again, continue talk folks do of on I'll we drugs carve year. I Washington the and then so space systemic that firm bundling. it to that we out to we'll engaged Yeah, to have dialog with possibilities like going from action push something know been in have senior actually in that But in this of see around macro, a for. But don't is the the specifics. John

But We'll I to some John have certainly three it would going benefit think the the to outpatient it reimburse] a first difference. talk on for make [ph]. years I'm side, with [chapter pass pass-through.

John Harlow

question, Yeah, thanks, and Gerri, so - good David.

Let what question be. where about me to market will then, reimbursement I'll commentary bit or is some going. on we focus - Gerri's think landscape our a add answer Gerri's we believe the little And

ambulatory unique in that the Code filing, we assuming HOPD calculations, all launch, space, those now. Code surgical file get different at separately Both a assuming miscellaneous patients that for we of So we the time won't C takes upon commercial time codes in approval Right both hear different the and we of quarter acceptance have October believe a settings be for J and I Code From Medicare which codes C patients reimbursed Code, it'd into C are care. would will of unique after as based for differently, and again, standpoint, and, of Code we C a of a then C which from approval, be and two timeframe used, Code, approval, reimbursable. miscellaneous J will can and believe Code.

Code, effect unique January and in time would of which We for of end takes to some into file year, the then will take also XXXX. J review by a the

products a standpoint. Washington to the and now going advantage about unbundling, What is the what's have are right And that's from setting, one discussions the bundled out of the going evolution currently also on in companies or think point, don't in-patient. an I within that Gerri's is other coding little from So just have DRG that, Washington, it's important the news To know we've another dialogues seen think our in is company. in right. company specifically which over the payment we with in-patient note to I all the in reimbursed engaged coming

all we're watch and As of continue and for We'll happen that unbundling happen. space the currently this it happen that having engage if anyone's to will happens, I point, closely that would well. is non-opioids. it's really will discussions But this when in as guess think at

David Amsellem

color. Thanks the taking questions. helpful Okay. That's for

Gerri Henwood

very Thanks David. much,

Operator

next Our comes with Trbovich question from Ken ‎Janney.

is open. now line Your

Ken Trbovich

least about here wanted are of Gerri, made Thanks for that issue to Did the in the correctly does go you expire And you patents it to saying launch? back that one the now as question. weeks. how be a to of picture sort going you Orange-Book you the for expected guess, I couple hear change so, at if taking I that comment last of to those I listed? see preparing in to

Gerri Henwood

good question. Thanks. Ken, Sure,

we So lawyers divisional as told those product-by-process of look at were one patent. as patents look by Orange-Book a at typically, are patents, in we three particular those And listable. IP product-by-process

that mid-year been other have Orange-Book be of expired be would at an that of expired roughly the at by And end the in expire And be upon have Orange-Book. so, new That that so of May estimate we would to of the anticipate that we get within and have would manufacturing process XXXX. supplemented XXXX. of and drug XXXX, end have listable the approved the that the would will this has patents we expiry related Orange-Book additional the the an listable would added of formulation issuance patent that in patent XXXX, patent non-Orange-Book

Ken Trbovich

I to Mike that on of and success attracting development got have manufacturing Got incredible the sort I you press. some side, to folks then, you alluded this, the business guys some And idea know, a credentials. it. had tableting contract some they know, the business, with regard

So for underutilized asset stage I'm even be the the early of some to think progress to eventually sort you trying you with when or perhaps might from able a that or to manufacture? a asset sense of a to get work utilized partially timing transform and commercial

Gerri Henwood

test so flock small good projects. you coming It the available And and of having think not are this to and for for the projects in lead I does bidding business projects. in meantime, instantly that a question. there come opened in birds if bigger part on Yeah, and of you're business And then, usually folks will.

in process, come to talk Mike are So but of of little right terms all this about the you who want attractiveness on bit page, that. a

Michael Celano

And - key that stickiness of capabilities also for our providing also Right. - that the we been allows standpoint. of is it's had already and customers for developmental metabolic

provide in into not million building that of have So ways pipeline opportunities, of we it the the to does upside into keep on Based our built that additional $XX guidance. relationships.

this this form year that But any we So point, guidance. into projects. additional of expect in it's build later announce our not to at

Gerri Henwood

So and they're certainly in in our it. biz interest for it

right So that's direction. encouraging going in the we're

Ken Trbovich

then like. was study other back the guess, dental And benefits wisdom more Can than model because the I where Got in been that II teeth. Gerri. there to give it play was label sense interest of with it seen may it. into of the in perhaps one looks studies? has for Phase from you last seem of how I what terms of sort higher for that question, dose the then been unusual in us done was relates studies, the dose, And impacted looking like certainly a help what study especially have the that

Gerri Henwood

that talked One, a bit we've it's about good that. a Yeah, little question.

be going - opportunities certain during And are that to incremental XX up that bunionectomy could is are in pain. and was a a of that related effect in which see practices the are comparable for it of dose, to the so a forecasting relief, even it health XX XX serious what And show XX dental they and bunionectomy, to finding otherwise, was II analgesic. immediate for that and where - because study better sort was is, our product. was we an That bunion in XX of up studies was routine dose, deal dental in the that common, not the went due of with good orthopedic and from meloxicam much we pain focus did current us did addressing, not and addressing an X, the XX pain next those period, more study relief, that was and mainstream saw early future molar launch we setup sort dose Phase area but that a that people and it we efficacy player IV unsure makes but are do on very possible thought level or effect So very lowest planning partnership somewhat the that are systemic we that area development worth which bunionectomy, third effective to extraction of in space being that on it's study II this were practices within pain opens the study, either ranging is reason surgeries be forecast. study of milligrams available. classical we there Phase that that in the was But of and or brings so

Ken Trbovich

models I a study. pain, trying And regard the language Phase - the not it's label studies I'm what bunionectomy for of that to you're the in Sure. guess, in understand, just with lot and make safety to fully also the a of maybe hoping for efficacy different you abdominoplasty, in the I sure, had III but obviously, for

as were label or the label you've of and I'm language for just as submitted of understand you hoping perhaps plan itself? sure to label So trying make fully sort the the the

Gerri Henwood

seeing it asked Okay. I you wasn't Good when point. first. the Langone

going of and be to not moderate on appropriately that believe that But is what soft of the or sort tied on that spectrum severe That in patients expressed have of really to instances that. we and based the from that's And And relied we management hard to interactions to FDA reflect tissue date. pain, the done. experience anyone yeah, an design to our would that multiple document concept guidance. pain FDA guidance trial we've instance in requested an pain indication for So for pain. tissue filing being of indication the

when in the to product, will IV we to hopefully, management. use So moderate where non-opioid indication tend use - see appropriate to pain from we severe

Ken Trbovich

Got you. Thank it.

Gerri Henwood

Thanks.

Operator

Our from next Henry ROTH comes with Capital. question Scott

line Your is open.

Scott Henry

Thank good you, morning. and

Gerri Henwood

morning. Good

Scott Henry

just I to with to the the patent start think want because with I to listing, regards Orange-Book question follow-up that's pretty important.

well, First, Orange-Book, getting automatically in into event, that as simply it make a a put as and far there patent you do have the meaning until is Or in procedural case goes the challenge. you that in in the you it lines. to when later merits as XX-month patent be can color the to that And so patent, along the assumption in making is any that provision I'm process that the know including Orange-Book? automatically if will those

Gerri Henwood

Sure.

more slightly first, start stuff. to go I'll I'll then and with the layout complex So

listing in stay. patents for when the associated Orange-Book expected the are So with XX-months

this different, by heard the application But and added meets that anything patent remain typically knows you listable. and all expect believe requirements been be based conservative than for about we've that processes we listing, patent from we're it's one process patent you product and we of qualifies up until one. to done conditional it. believe, believe patent to knows wouldn't that and product should the this We we the make So Orange-Book counsel process basis by me we've Anybody but that more that what for and write listed characteristics got that an the needed. which you the product. we've will in The on

the it proximate subsequent right date provision the - these on that or you findings to filing whether Orange-Book. update approved initial bubble you is any We a there or would or NDA we your listings to additional now, when get amend Orange-Book filing the have to impact that an are it's so is filing you any

additional notification we So meeting definitely one exist timeframes we're of so on of equation, that side the the of for other Orange-Book that patent. will that be

Scott Henry

That Thank is Okay. you. helpful.

we As time let's need well, to date, drug. you XX, lead-time approval launch much between you the PDUFA would on approval say, get much the on May how How do expect?

Gerri Henwood

to the of Yeah, going discuss have in so through ask sort would to field. in macro we have point until that steps that we I'm John from folks would the

John Harlow

Yeah, good question, Scott.

formal So we've to will hiring individuals weeks, offers. had from organization. comprehensive validate onboard compliantly middle assuming set our ultimate them in approval to then have and contingent our response these to contingent early force We few building that anticipate we ready prepared launch, over is and ongoing the offers them the activities make to very July. them to And overall a offers their get sales for program would of skill training in transition a next tremendous June, those the and plan plan will launch

Scott Henry

understanding was place accounting a XQ or QX? Okay. Thank my dip the on you. That's you expecting changes took helpful. And then, the final And in question the manufacturing QX. Are front. in

those factor that get Just I So or to XQ? that would changes some should sense into affect of that already trajectory. trying

Gerri Henwood

giving, I'll gift Scott. But let It keeps that. the that on is address Mike

Michael Celano

Ryan. ahead, Go

Ryan Lake

there fluctuations quarter-to-quarter. the new be so some based Yeah, is less, on or more shipments so recognition will revenue standard

to received we some addition contract from with that that type of customers. patents that manufacturing amongst lumpiness fact ordering In there is business the the

again, as earlier So, $XX and feel reiterated earlier the we as Mike confident of what we guidance that we very million. reaffirmed in

Scott Henry

questions. Thank great. taking you Okay, for the

Operator

Capital. with comes Our Berenberg next from Trucchio Patrick question

Your line open. is

Patrick Trucchio

Thanks. questions. I have Hi, morning. good several follow-up

then will for you meloxicam, IP just can And the soon-to-be-issued IV the IP this impact of NDA matters, if it's why filing substances, meloxicam? for announcement, how IV the why First, the patents discuss the important on flake-like all? significance at

Gerri Henwood

thanks, Yeah, Patrick.

set in preexisted has would standing short-term like on being Pharmacopeia about the that to this, we flake-like not you no, it what that certainly manufacturing to patent around me clog the nidus So of acceptable this solution. of hear be as of a in very standards risk go who that. important because cause believe that in standards, That's Those clinical we intrinsic was under product, be able product who on why approvals to of of meloxicam not and the many ability USP hasn't to most formation pose could U.S. substances believe form has. terms used, theoretically, recent

making, So the came to that parent method being product-by-process it an important and the facts we've knowledge patent. of on allowed method than form looked is avoid category patents, that these patent, Orange-Book that different as unobvious patent us occurrence. forward, of the an further making divisional product-by-process because patents of for were that allowable including based of These and

created we normal safe and the use the important So administer and label. have and shelf-stable to in within confines to terms that - it, of think clinical remains to be importance is the judgment of product according is of

would In we on the way impact this it just that we the has to We following. that now. terms impact one other taking or at guidance right the are not be an We're see want on of sure NDA, NDA.

the listing Following pathway to get the to it appropriate a added fashion. Orange-Book in timely

Patrick Trucchio

the revenue meloxicam the just Okay. are can change IV precisely on then And just you policies, recognition the business impact impact and how CDMO recognized. discuss these revenues new how whether will

Gerri Henwood

Knowing pronouncer Ryan about that. we'll goods, accounting of have not Sure. talk the that to I'm

Ryan Lake

the by customers. streams the it what when And portion requires do agreement CDMO was under as is the most product guidance that sold we us customer shipped agreements we where a the to really for that manufacturing license Yeah, is recognize. for revenue the our business our reported our related accounted be significant those when of recognize separately couldn't from to impact evaluation concluded versus revenue of that the previous

look judgments and well But year, as there go incur, forecast into the that slight a estimates lot as and full as projections look year to for are we those our or and projected as the patterns, out we at we customer for that a of was unfavorable to the have when we full prior and favorable the the those shipments we're saw - result expected quarter. at are estimates a first expecting projections it ordering that So as impact in-house of compared year. the

Michael Celano

million that's our guidance. And considered in all $XX

Patrick Trucchio

so Thanks much. helpful. That's Okay.

Gerri Henwood

Thanks, Patrick.

Operator

question time, Jonathan this National At actually with comes I'm next Securities. our from - Aschoff

is now open. line Your

Jonathan Aschoff

cash the that if last? approval Alkermes and you the Thank remaining assuming you. long have, how drawdown the was I will any triggering wondering, of debt milestone

Ryan Lake

is question. Thanks the Ryan. for This

March the well $XX launch million cash. cash tranches pipeline help non-dilutive provides fund support we as would we in which our other out raise, that $XX So Acute existing the the look another $XX.X facility months, certainly, from $XX next will XX And as from in anticipate principally we and expect Care from million contribute business, we to activities. approximately we ended financing million would to the clinical well Athyrium flow remaining CDMO free Certainly flow have. cash million also the equity kind with post-approval the that, meloxicam our annually over as non-dilutive in to and cash as the which

Jonathan Aschoff

Great. forward approval. Thank you, looking to

Gerri Henwood

Thanks, Jonathan. Cross your fingers.

Operator

Our Gershell next comes from with Leland Oppenheimer. question

now Your line is open.

Leland Gershell

question. thanks morning, my taking for Good

the question new more one on IP. Just

on of the to you could might comment how intramuscular issuances If meloxicam. how carry-over formulation - that those

Gerri Henwood

analysis data So of at syringes. this time, the pre-filled compatibility more the form that, to dose the some of would with that applicability await

of avoidance course that So IM it's the an issue not as the substances as well. for be hope flake-like - we be believe of to would of product easy key the would But predict.

So we we demonstration But ensure to should that that is there would date some applicability. is the be more need there case. believe

Leland Gershell

and question. one just Thanks, then pipeline

blocking that neuromuscular mentioned those the agents that clinical you you of one had On stage. taken is in, had recently and reversal

If that comment for and you Thanks. advancement your sense what that is on compound. the one near-term are could which of

Gerri Henwood

Thanks for the Leland. question thanks. Sure,

intermediately is like. instance, intermediate successfully are injection stage. volunteers blockers, can that paralysis, at to of ability in agent be the used prior are neuromuscular which be principal, paralysis, to or in the agents the and that look for induction The or the could clinical produce anesthesia suppression a And trial the agent for So for continuous clinical those. such duration in surgery it human single used in is reflexes, conducted a abdominal as of RPXXXX is two profile there infused an of to had intubate that trial. it's It one favorable and had that subject tolerability by

There profile. expansion are with of a to some the explore meeting had limits, like that recent tox have We FDA to development somewhat because higher doses. we'd discuss

in agents an where But we good to file API availability the of be assuming ability Thanks, either IND, we or year. is initiate gating of studies could tox one then of of an this we that hoping late the for is are calendar that and of are to are some IND file before and both these the And position acting that ultra-short working quarter year. The the agent to Phase the is hoping factor. a bit potentially and one have we question. little that so, performed fourth have RPXXXX the we towards another in completed early end I possibly next

Leland Gershell

Thank taking you. questions. Thank you for Great. my

Gerri Henwood

Sure.

Operator

to remarks. questions. for showing to At further call I'm this no back closing like time, turn Gerri the over I'd

Gerri Henwood

Thank you morning. joining us of this you. I all appreciate here

the and manufacturing developing and efficient across committed Care have date meloxicam We on with other fast these effective the strategies both remained company. and contract approaching divisions well development for milestones Acute and executing the upcoming PDUFA to and IV development of plans

your time to certainly on sharing again the Thanks is we a great day. us for forward updates in Now time. company and very the near for exciting look future. Have a

Operator

conclude gentlemen, for does today's and conference. thank participation in This you Ladies the program. your

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

Societal CDMO (SCTL) 9 May 182018 Q1 Earnings call transcript