to peers, our beginning the Well, morning, lingering impact patient visits. have mostly the take job space, tremendous the has the although chemotherapy thank you, challenges, conference industry the and industry to effects to especially waiting Good across return call open face access for vaccinations. The holding and some oncology COVID-XX and felt in their of up, but continue off for our washout it Eagle period Oncology down in treatments providers all this were of visits oncology to country’s our everyone, levels their fewer today. to of to time pre-pandemic we visits. the patients these quarter, done a like those effects may of Lisa. welcome for
we chemotherapy because quarters However, fell are visits than expenses normal up year. mainly the a R&D return quarters, same to for our in bit into this year. previous expect four to time, the the At the little way more of the
we of The anticipate down a has stock -- the over been come alone is company. focus, an course, that buyback standpoint. next have an years. been higher the of significantly market I had Brian with is ultimately and in exclusivity and $X.X of year four XXXX, than has our next and XX% The will ultimately in launch expect a past but a significant from revenue to the how ESP months through earnings we We creation acknowledge XX, shareholders grow taken walk year We believe billion the will the few we be from the The we you for In and PEMFEXY we on slow a to approach February significant. pipeline lead the company back our in rewarded. should and quarters. be bounce sales three process, to moments. expenses will of great value both And our of numbers shareholders.
we large this combined through we presentation, launch. pieces vasopressin all also go lead this of expect to will week week news two hear that the These two with you a reported of today’s As should out good events past -- Japan this growth.
both also substantial touch the in and pipeline, base making on our in-licensing. organically We progress are we projected will
our continue to We and have growth. to these for unprecedented adapted growing ourselves positioning business focus and times on sustainable
for on our program completed Let’s obviously, provide discussions were conditions. and need is to About that a two at the appropriate previously. tracking study progress also since the we to vasopressin, hoped just with FDA the experimental exactly study a pilot us. the with expected. final starting to ago, meeting, clarity and the final provided as on now, FDA look study. The call conditions the we the Vasopressin respond completed at ran we study as pilot critical outlined designed that study for last the as data months the post-CRL short-term and clarity for two results ago Based weeks
and shortly ANDA is our in XXXX. to shareholders will here U.S. CRL expectation study for is of relatively previous be respond we $XXX We CRL The remind which to fully will soon amount the a time require the to our everyone FDA. all the time that referencing and in we this, we midyear. total I audited will these and which be full are on some then results will weeks accordingly. vasopressin, response this, sales to million short articulated, to final receiving available final a of few a then will we timeframe update by in had and send audited file report the prepare after Based this results of first takes
as currently the is priority. by COVID Our and FDA flagged prioritized ANDA also a
to note that specific necessarily asked are Eagle bring to that want questions Our we will we the believe the in questions those asked approval be FDA plenty molecule formulation. product time of ANDA majority year. expectation final the this of of market not receive Furthermore, We remains holders. questions to will by to
has well as we held all up asked attention formulation questions to far, FDA robust and now the to thus is Our turn our us trial. patent is
from If you a non-infringement The easy to when product involved require range. the that pH you range it relatively prior X.X specific vasopressin pH statements, X.X, is understand. our our trial break patents the a within for in below case down to specifications recall a product vasopressin of while the require
and can these litigation. this which if manufacture we should we our the X.X X.X, outside So in to of it specifications, maintain of are pH prevail range within product
scheduled more we have us close tremendous to delay is time we a lining significantly to we the for appropriate are all a and delay, gather to in of conclusion. trial Therefore, that us, the was somewhat since feel that of has within a additional and collecting Although, the There manufactured delay the XXXX, has the May been of pH amount with maintained silver data in-person, extremely difficult been our the back the market positive. that initially that is of court our be non-infringing allowed been we taking will assurance of to all again, days bringing year court to later launch has proof the recognize the anticipated. which to our end that the responded now. pH XX the a to during process virtually. than expectation We trial CRL we case trial and forward But our had that and become soon of are end. coming being to we within we from strength not will by look The place believe is of now product range. of We that clear We reiterate position week. the product
that schedule. filed lymphoma in used We market have the TREAKISYM B-cell the of for diffuse to meaningful from Agency in and ready was significantly liquid bendamustine pieces the announced SymBio approved rapid with by the they had excellent XX-minute Pharmaceuticals believe a indication application Japan, for treatment Medical is also of Eagle or of it formulation Devices another formulation rituximab. last name large TREAKISYM extension news coming marketed SymBio will two relapsed to bendamustine and and for increase ahead under dilute for new This trade have opportunity week, liquid for product out latest their the our refractory for our just approval infusion And we Japan. license franchise of the combination
has the that coming filing Over early peak as selling these as $XX XX that income and believe XX-minute to as products and the can from of per been the peak we and million months, will TREAKISYM formulation, we year. well at level anticipated year. the recent milestones approval, close past approval get believe million the next as royalties Based on $XX we contribute
the PEMFEXY, from Moving away is PEMFEXY on now. only launch nine to months
XXXX. of four sales of in and Lilly and nearly in with as As $X.X final you in market, recall, we December totaled months a we FDA of received approval February have XXXX will of where U.S. significant ALIMTA XXXX billion exclusivity. settled It’s
approved also the are PEMFEXY for even an vial, larger We for us. making opportunity multi-dose
As coding and you This exciting access provides insurance. patients and our for Medicaid J-Code, granted which outpatient and physicians, from and is we reimbursement were facilities clarity time commercial launch. to facilities a unique to know, an leading Medicare, up
between is more into vasopressin I waiting milestone launching realize will royalty close branded we bendamustine that million hear be to is vasopressin. get of now by peak and and $XX should is news Japanese next months of as sales label our expansion news mid-year year. as the early nine and good are within and billion shortly. on previously happening $X that trial PEMFEXY, revenue disclosed We The of everyone us our re-filing to
be this get finally will more a patient. We us bit and to just we little have behind
Now fulvestrant let our me touch briefly on program.
to plan a prior those results and upon formulation we trial. consult to starting work our clinical a We FDA then have study with Depending small expect run the to pilot shortly. from results,
work ongoing, nerve to as data available. continues, the RYANODEX, becomes we on report our it expect agent study is the Regarding
have comments some also new make. directional important We to
As we cancer. to co-promotion on treat searching to augment their such our organic updating for SM-XX to you We been forward have further in-licensing One look agreement development. have acquisitions Tyme pancreatic product and we with for Technologies here. is example progress discussed,
in we finalize provide in-licensing now which it is for that criteria few meet opportunities additional a Although broaden are EPS long-term. and portfolio our would short- transactions, leverage pipeline. bolster aim to diligence the would premature several We our capabilities, stage considerably to in and late and our our details,
to expert Borio, Board our career Dr. warm her extend forefront who to Directors. former a of Luciana challenges. like of the renowned welcome addressing public who has I’d most policy is official of and joined recently Dr. at complex FDA world’s healthcare the a Borio spent some U.S. Lastly, healthcare
are forward consistent a provide and future and TREAKISYM look of we together, very excited to all stream potential vasopressin, revenue as we XXXX, XXXX, Eagle. to the XXXX which Taken about PEMFEXY have for
cash to net time, current that, PEMFEXY expect the and portfolio results. that will significant have and we strategic exciting of cash, launches important believe along our At some the vasopressin Brian therapeutics. the promising call our our generate over position. first discuss same We quarter turn to With broaden Brian? Cahill will with transactions I will we
