COVID-XX safe Thanks, Robert, with We we highly all families everyone. know, afternoon, you well. unusual are hope times all and impacting of are, your These and as us. and good
normal our health the Seymour, essential during as supplier remained to provider, population. Indiana Accordingly, we service Lannett operate like New heartfelt essential resilience manufacturing along I'd With to the with in providers and thanks Lannett that have services the begin who some is York pandemic. everywhere, first and vital to and Carmel, mind, of medicines, have crisis responded responders welfare regarded significant our at of plants a with open and an to to of As employees dedication continue challenges the with the capacity. and in
forth continue put Our have extraordinary medications. patients sure with supply and employees make to customers important to we our critically effort
has weeks. to faulted that proud not past are our share these production plant We
focused to and To effort, well-being. their aid first of that we We followed enhance on other number any measures guidelines our safety. employees' implemented CDC
for implemented For example, for able to do working those processes so. and procedures we remotely
We and all on-site visitors. travel suspended have nonessential
our personal and working social increased shifts safety enhanced facilitate we manufacturing equipment. staggered where our we possible, have protective and and distancing. physical to teams, additional provided R&D And For protocols and rotated spacing
have them provided benefits operating and COVID-XX-related time strains. focused help our additional to personnel other on cope We off paid with
environment. cGMP operate of to regulated clean a fortunate, are we already highly Finally, and course, in
employees happen. As thank again this And business of employees to a impact COVID-XX been made our has our the and who hold minor. we far, our in result all environment relatively so efforts, this redoubled on our
key The far, only record some associated supplies With by for associated of our affected customers their certain agreements Again, COVID-XX. with COVID-XX, largely post-levothyroxine that, challenges sales net let's at $XXX products era. our chain We take earlier financial been increasing such has as products to shortages. purchases and and of the some our a demand appearing higher-than-expected and medications thus to with reported patient amount address XX,XXXrd results. were of of in avoid referenced, closer sales our supply a modestly purchase fiscal result quarter patients million, extra with
gross a expected, we price and, extent, largely percentage to due erosion. lower product Adjusted sales to for mix than was lesser the quarter margin third
As profitability has an us and from provided sales think aside, that capability. benefited disruptions receive certain flexible of our to product margin help in past, our average. manufacturing often Supply and awards I sales it's are say above the the our alleviate to opportunities were recent fair for often temporary shortages to these
during low. More review it's at optimize margins products average. Over important recently, to customers, believe offering. however, to with and to market by opportunities will opportunities do to We however, we for part patients provide continuing time, portfolio even below to the continue critical margins were assist our are often the or pandemic our medications for if our
Turning our guidance. year full briefly to
and We assumptions, including, raised first, revised the range several we have have on the quarter, we trimmed midpoint, adjusted sales This based held EBITDA narrowed Primarily, which elements range. sales. durability guidance have posaconazole certain in last our fluphenazine but our is and outlook. of we our continuing
indicated previously these expect not to of for expectation we see for balance that competitors new You year. the current the fiscal unchanged. products may that did we This recall remains
the level On will our a reduced during elective significantly fewer now high-margin given of we be surgeries lower the recently hand, for launched the product for other far this Numbrino sales being performed expect crisis. unfortunately, NDA. the Demand during crisis,
down. the winds to once expect more see We COVID-XX meaningful pandemic sales
finally, both our commercialization the throughout note posaconazole. leverage year, slightly of the products capabilities new those reduced or partners, item our model that business this and Another abroad. strengths agreements launched is and to value embraces with complement our of our here And excluding guidance of opportunistic
to slowed well shortly. detail as the While continue will financials guidance approach John opportunities, such we our discuss revise in has obviously more during as our high-touch agreements pandemic. many progress to somewhat such
valproic fiscal XR, Numbrino, In XX January launched of year-to-date. of X, products, first And Regarding have solution, X solution, products. product oral nizatidine propranolol solution oral since generic year, for additional oral a fiscal X launches. we the Adderall our lactulose half we and ER, products launched total including
in before XX. commence queue products several we'll Over for more launch, which will of have portion the the June next marketing a several we months,
of environment the will our current fiscal February for competitive operational of launches readiness, million we expect, the to million $XX excluding posaconazole of that lower given of guidance. timing we in and perhaps million than expected new sales over our product $X However, $X XXXX, be all
Most received for FDA we recently, ANDAs. approval X
from maleate, and The combination a hydrobromide and per mouthful, pseudoephedrine hydrochloride, XX-milligram X is syrup, triple respectively, brompheniramine of XX-milligram, X-milligram, dextromethorphan first that's ml. a in
value, suspension date. due they We also XX oral the less clobazam approvals received both for expected approval are fact received but for notable first-cycle X product their These their per approvals X.X-milligram sales submission to future review from months ml.
by of the our achieve the market. an can speed get for quality submissions both ANDAs currently them sign Only reviewed first-cycle we approvals are of and approximately the FDA XX% approvals. encouraging to Such
our the file addition, form In was brompheniramine internal approval. suspension dosage first
products suspension we in years. which to We under have development, coming look other commercializing valuable forward more
third a ago was hydromorphone time favorable. oral A solution, approval market legacy at conditions more were hydrochloride several a filed when years ANDA
current the to conditions, not market Given unfavorable currently product. market are planning the we
in our Regarding than products products, and ANDAs pipeline, we now plus including approved about at that are development. more another FDA, And the pending partner products have pending X launch. XX XX or so
complex market are resources players to develop relatively transformational. Both generic Not glargine ADVAIR only products. the for quite the our these of a addressable and biosimilar technical each opportunities small manufacture only product these candidates. insulin but and, possibly product large, significant in number Turning requisite have and together, product is to expertise
our to product partners both are Fortunately, the committed and success. strategic possess
products to market risk increasingly both are As and dynamics we factors, and advance, becoming continue the optimistic. we assess
design a and additional clinical and we subsequent guidance any product's regarding human to find discuss plan the the license At advancement. a glargine, next the the the will as glargine including biologics approval speak insuline insulin endpoints on meeting, program, to required biosimilar. Regarding June ongoing are set steps to the provide studies FDA for with FDA of to development X, of XXXX, the application
COVID-XX this to to ADVAIR. as to file trials Turning we PK overseas situation the an begin months. currently year normally. later an site ANDA of within look impacted X European now ability expect clinical to generic calendar Nonetheless, pivotal operate the the We
as studied COVID-XX. product possible our the currently World Finally, lopinavir/retonavir for products, a noting of solution being form. for treatment in it's combination worth only-approved is the our and We combination, one Health the by existing this Organization is ANDA generic market
supply is on percentage not far the able demand a The basis, absolute so been have recently currently is a substantially for product contributor sales. modest we While that significant. increased volume to to
for showing book. However, effective treatment as the should we flexibility to certain a in patients, FDA solid Note COVID-XX and dosage the the production up there are quickly. medication orange tentative approval capacity have prove ramp other forms
several the we products up, more X to health across public operating months. prior strong We demand are as January expect launch and coming with were sales excellent crisis. we sum We to multiple introduced same production reported categories. since net new to currently product in COVID-XX the the To X expectations
certain for net gross lowered We like but impacts and emerging mix, we guidance, pressure on have expectations margin on products based sales for some products sales COVID-XX-related Numbrino. have held our competitive
As result, trimmed our adjusted have a guidance. EBITDA we
products to strategic continue partners build market alliances opportunities have of with on continue large advance pipeline We capabilities. products, and additional to opportunity sustainable and our to work that we complementary
with supply and to the help are manufacturing R&D based to part, medicines. national Americans not and the we also dose last, support U.S., And to as in finished interests of its a be domestic security only to proud headquarters able expand company looking employ all our do own but its of
I the to over turn that, With all call John. John? of
