will fourth And an the products. Biorphen performance, quarter as our quarter for our session. CFO, David, well update other I'm you a with achieved milestones today, Troutman, as important discuss of Q&A was for you, Thank some thank The you, pipeline extremely that, company. and After we'll to on important everyone, close an then share our excited with with today. joining our us Wilson and financial
So starting off Biorphen. with
Biorphen of quarter was was the in X.X hard team's launched our product in As you achieve first and and This for years was launch a just proud in fourth December. our milestone the of most commercially critical after company, know, very approved I'm work inception. to
injectable formulation Biorphen unmet ready-to-use As a of within phenylephrine, the only and first hospitals. need fulfills critical
introduced to calculation In offset would This formula phenylephrine some order had this approval, purchase errors. to hospitals concentrated due order compounding use its it. potential also both and risk, to facilities. was in dilution from to hospitals manually a dilute unapproved and time-consuming Before risk
risk this reality, cases. in most true reduction rather However, transfer a just risk amounted a than of in to
shelf hospitals, FDA-approved With the savings a patients. product for we most longer of have Biorphen, an provided and, life to now cost introduction importantly,
a have of advantages that has a we Biorphen. to ready-to-use in hospitals a was Ready, of ready-to-use Xellia's Biorphen promote Biorphen. to the the money first, products focused the announced have certain a will approach both Xellia's win-win and with same sales with Xellia's relationships faster in injection, Xellia the us adopted promotion vancomycin which importantly, proposition save past. existing Eton: of Xellia should to partnership be it hospital-based co-promotion target Interactions more previously significant lead several Vanco existing point sales force the will for and adoption for co-promote has since U.S. that formulation of significantly onboard, call increased This Biorphen on value of similar strongly due for companies. we a brought customers it January, amount to In will believe we segments. with customer and force SG&A;
strong, has hospital Initial placing have institutions since and over different each we unique. XXX already for interest launch. Biorphen -- orders Biorphen onboarding in process had over The we've been is had for
departments and hospital, the some institutions, you typically multiple line. before the This imagine. longer to conversion on a Some within committees hospitals centers a converted time X- week, the Biorphen is, The and others, buy-in let's to lead the say, to as a converting. process larger can larger require X-month, while delay for surgery can
more and of third We pronounced expect we year. see and pull-through quarter from benefit expanded are to see second reach, in starting this Xellia's the benefit to even an
specifically following excited hospitals directors at of the Pharmacy aspects our Biorphen. target been have about
product's FDA-approved manual risk shortage. product. physicians and The unusual in this lack pharmaceutical the is of a shelf time saves life. error and First, the of to risk the reduce It calculations, the allows status. X-year in also dilution using industry. the reduces product Biorphen them critical of stock This has And and medication thirdly, product
known many the been previously some facilities. experience purchasing which customers our compounding from to are of disruptions facilities, XXXB During unapproved of that with quarter, had they as supply continued phenylephrine
on As PharMEDium largest many in leading this phenylephrine no of not compounders or significant. the the sell one compounded saw, January business. allowed of been you one believe United probably compounders but the compounding previously in the products. that are now shutting was Biorphen AmerisourceBergen in of the We -- has PharMEDium Supply of is longer was This just one other completely announced largest been product had they to disruption approved. regulations, based in that FDA's were compounders States. down
communication compounders. legal regulations with with facilities, are and the counsel notifications enforcement we sent compounding their regarding to FDA engaged of own Our such these against
have to this meeting the in FDA expect an continue with discussion. in-person to We April
to purchasing we front, coming I months. on in secure over organizations, first progress, We and X,XXX to that to pleased we the GPO GPOs expect secured with am X, the continue and contracts discussions with our contract February good make other in group additional institutions. On Premier, serves GPO which remain announce
size, believe market addressable is to Regarding phenylephrine of we units more million the XX Biorphen. year than continue market a
million are the phenylephrine. to to term the market. exiting compounders supply many and least more and remain We enforced manufacturing ample ready-to-use capacity to potentially the units manufacturing is market that has if lead X goal at Our partner confident capture long for our FDA regulations
they existing XX prefilled that vial and which launch as NDA, potentially initiated months. an system. point line the for these pleased a customers, Biorphen price container believe after conversations with introduction of extensions, we in been both a and we premium the to convert strong at file We've to on multiple with market the expect have also the we demand next more to a could we've an work syringe opportunity with in While supplements initial ampule, of our
to days for A December, addition exclusivity are of to the an first-to-file product. make XXX to have the would this upon we're ANDA great pipeline in successfully we innovator's continued we advancing major our the Biorphen, We In candidates. submitting entitle generic patent. of us believe ANDA progress DS-XXX. This developments on include, late-stage few challenging
the submitted market amendment more million so is FDA that Bausch to December, the remain this estimate annually, $XX opportunity. than DS-XXX excited for addresses to in the date our also we this product completely an believe raised Health, FDA, of approved the the target Also, all very We in and EM-XXX August by on issues for action about year. this the be partner, we We a amendment expect current product.
the the revised ET-XXX label human the product, confirm discussed run minor to factors of as lamotrigine and our and On make sections to we XX, on February product previously a instructions. follow that changes has administration we the study requested dosing can caregivers FDA
so to receive complete the expect a by to unable study PDUFA current CRL. be will We the date, March XX we
study quarter the in study and for the weeks, allows anticipate this submitting which a still protocol to in the of fourth or We third this year. and we to FDA the potential during approval year, second of are resubmitting quarter FDA coming the completing the
with full made for and the this XXXX progress the happy have our quarter advancing we year pipeline. I'm
year. pipeline the we growth to X pipelines addition and we many review expect X the file this sustainable later the of With in to additional have filing products in FDA now that of for DS-XXX these products come. the we we products XXX(b)(X) the strongest under one the years for to quarter, provide expect industry, and with believe I have continue fourth to ANDAs
continually importantly, actively high-value pursuing Lastly, and development to say most perhaps business like that would I opportunities. we and are
and provide development that revenue. the projects hunt strategically can fit our for on into late-stage near-term are We portfolio
While it's during ability predict optimistic deals, to the to future about close impossible transactions are year. timing we of value-creating our this
Troutman. With CFO, to our turn would Wilson that, I like it to over
