afternoon everyone. Robert good and Thanks,
served XX XXXX seek including time Farber reelection the to acknowledging Board begin and year. of of Lannett you involved a Jeff not of Jeff as long to years, with last Lannett’s member today the decided for know, Board been will the from has a to Directors many this Chairman XXXX. As Farber, who family I for
last experience his from several continue and counsel will we benefit Jeff the for Chairman over number to we through of have support personally navigated I as challenges. thank and a his years insights as However, Emeritus. significant
continue an the be advocate team. will As and Chairman an voice the for he company for Emeritus, to Board and management appreciated
stock of last aware, our Stockholders. in proposals outstanding approved common to all as X, p.m. at week, report minimum of XXXX Next, York the for company’s February on the company we intended including Annual with are formal Stock Eastern the Board common X-for-X by on authorized stock bring maintain that Meeting pleased become the split a price New bid split-adjusted The and is am beginning basis. XXXX, proxy on effective will the of X, the contained to Lannett’s day, primarily most the listing of held split stockholders, Exchange. its I our issued stock into reverse and compliance next will Time stock were stock. trade February X:XX requirements the The shares of reverse split you reverse
the overview. to turning Now business
environment competitive have business, particularly some First, results the in after fiscal our years. our base in to couple expectations thus due part last of news challenging over the XXXX exceeded stabilization welcome financial our far of and
GAAP pleased am each gross Moreover, expectations. measures the increased to margin note second these above all quarter, over margin, two sales, were For our gross preceding the EBITDA adjusted I quarters. net that and adjusted of
million. cash expected, additional our as as results as color We refund A provide income our later, receive, pleased an on $XX to will are also John tax bit of position. approximately well
along positions additional company’s phases implemented streamline plan recently remainder operating to approximately year. restructuring and we our the in of be further cost with actions and implemented in the result quarter XX workforce saving staff On the last of reduction will vacant operations. XX realign over and These another a positions current front, will fiscal approximately
Philadelphia, annually. the to in facilities $XX Torresdale is million end Once and approximately cost implemented, this generate Road year. of expected of State our Pennsylvania fully plan savings exiting by anticipate also the We
plan A that the of key element of restructuring operations. involved our R&D
which development related more more this have the invest and one expected department to providers. and to external other We overhead this from cost expenses, internal and of fixed specialized savings, pipeline to scope in more We model broaden development products. to that an begun efficiently partners are allows with process technology us transitioning largely addition in believe cost function that the valuable the
is point pipeline maintain actual to in level plan product our I direct that out think investment of to it’s important development. our
glargine to biosimilar largely I represent these on on thus dollars these the for will Overall, value The continues an for and the commercial pipeline insulins firm. products. the aspart updates now turn timelines annualized aggregate to of and estimated billions and track. begin insulin in biosimilar for remain our transformational potentially with our insulin market products
AG the in as for delivery both products injector agreement a aspart pen into territories. insulin products, For our entered device biosimilar as certain U.S. other and well a supply insulin glargine potentially Ypsomed we with and other
improves things, for other market our related approved. litigation Recently, our between acquired once Innovation ability sublicense under we of pen The a agreement, the the to used and a various also device holder avoids Biologics reference the Competition Act our biosimilar injector certain arrangement and glargine products. product to patents Sanofi-Aventis, device licensing sublicense products to Ypsomed insulin among Price in and the freely
no as earlier our insulin events were of program, For volunteer and disclosed, study reported. healthy long-acting we our the have serious completed dosing adverse pivotal glargine subject
be expect continue and to top during the data to We quarter. analytics current line available
pre and Application calendar year XXXX current License review FDA an anticipate Biologics middle likelihood the of we to mid-calendar intended range. product Following in the filing the potential of launch pass approval a Thus, the shorten around increase the year. first time, remains meeting submission of potentially a
aspart, a Next, biosimilar insulin fast-acting insulin.
our generally the an comparable. said, products U.S. reference we by As positive insulin this our announced the of NovoLog. were of XX biosimilar glargine The aspart that highly versus insulin Last animal indicated we have months. XX biologic results the program approximately timing product to trailed month, from study study
and a this then would biosimilar filing of meeting biologic or commence development trial year Type summer potentially anticipate trial product the investigational the calendar X complete pivotal the towards fiscal We pivotal and fall half filing end in an successful, year BLA XXXX year IND drug year, summer. the this If later in of new the we XXXX. by we of product the launching calendar the the XXXX. this Following of anticipate back application
new granted I’ll with middle our franchise. expected filling product calendar the and is Flovent following application, or ANDA, for April, respiratory our start to with scheduled of for abbreviated meeting around FDA generic complex Diskus. request therapy the FDA the competitive of The Turning the earlier the status generic current development drug the year.
letter initiated. generic anticipate new continue current from the been For product, ADVAIR from that the DISKUS current trial the year, that calendar to to FDA a clinical – has additional responses will the results over a of complete we include response providing
New pharmacokinetic around be intended year. studies next raised year. in calendar will other launch matters to remains the address possible CRL mid-calendar mid initiated A by
generic around that have later for Advair will efforts Flovent our Spiriva development programs. expect note they Handihaler, for their a prioritized study Finally, partner we the commence generic that now, and but generic this pilot year, PK
and thank, these continue critical to to insulin colleagues help need medications associated in are these of with We and more bring diligently valuable We despite patients our appreciate see work to COVID acknowledge to who programs and dedication recent respiratory China. particularly pleased affordable advanced that the challenges overseas them.
the short to during Turning products potential be track now contributors meaningful launch particularly our current Fludarabine, on improved for moving through injectable those is opportunities, forward. currently partner. supply to available that partnered near-term in financial the our year. an now product remain more product have results to Three fiscal
We delayed and release and anesthetic fiscal Also on Mesalamine tablets expect and IQVIA of $XXX respectively. Mesalamine million, $XXX Fludarabine later label to year. million X.X our grams. launching is product, reflect sales deck sevoflurane and approximately inhaled this Sevoflurane
lower, be Although approvals. active actual generic just reflect three currently ANDA market both products sales will
So the to believe now markets order respond be calendar Sucralfate, year we attractive. we CRL. anticipate in launch the recent to With a regard possible to current outside a will
development contract our to manufacturing Turning business. and
sales of to midpoint million substantial over We are $XX year. the our a which $XX to million, forecasted increase range previous the above track is on of achieve
with working We in nearly two parties dozen interest have us. potential are expressed engaged with also that
believe to this grow to further ample continue business. is we So opportunity there
competitors. past actions, related including at in And over to year several warning or significant been pandemic, as to this quarter, fiscal million we have alerts, poor have finally, last has post FDA letters yet around competition related product continue for competitors our Further, not certain new excluding expectations, assume we noted where in-line new to that picked plant for the the we Fludarabine, Now and so, forward major products as up even import forecasted inspections and announced of materialized. $X pipeline standards and half sales back the launches, manufacturing of year.
October few them We inspection our are only critical from there proud plant Lannett, of are that a in none XXXX. an at at observations, Seymour
record intend to with continue operating FDA standards. compliance certainly We exemplary our in of
have some business believe long credible recent be reliability the we this based of upside a of into the high-quality and partners, quality and we of our our built medicines we to can supply While and on of plan provide. the of forward that not history our stabilization our supply attributed of
up today’s remarks. sum To
For our margin sales, the margin, net second estimates. adjusted above gross with quarter, results EBITDA gross financial we all consecutive better-than-expected adjusted and reported
of pivotal clinical anticipate current top BLA filing from the glargine, For the the middle year. anticipate the and the current calendar insulin biosimilar around we line results trial quarter during
For aspart announced aspart, our study NovoLog. we comparable month, insulin biosimilar positive biologic results the that U.S. an was animal indicated highly biosimilar last reference insulin from to
we that We reflecting receptivity medicines. reduction be And approximately recently the our financial million better-than-expected once guidance, savings year related of implemented value cost plan finally, what and part of estimate generate a improving in affordable to our full restructuring first of customer half to results will raised we we supply XXXX to an fully high-quality reliable, $XX our annualized believe implemented.
turn over closely. review will With the financials to that, now I John? to more the John call
