SIGA - Earnings call transcript Q2 2022

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Operator

Welcome to the SIGA business update call.

Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or changed circumstances after this call.

For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K for the year ended December 13, 2021 -- excuse me, 2021 and its subsequent reports on Form 10-Q and Form 8-K. With that said, I'd like to turn the call over to Mr. host. your Gomez, Phil

Phillip Gomez

taking by to and Dan CSO. Hruby, for Today, Dr. today's I'm our joined Luckshire, the you join time call. Dennis Thank our CFO;

business, have We'll shareholders. be happy to We to questions. then this take pleased financial update to provide are a R&D to and our opportunity

the governmental comparison We oral health that activity this last potential orders One as in who elements. Of international of and through are of large result been has ecosystem global usage to broad international versus procuring international a million initial inquiries we've over been XX this on year in entities highlight the regarding in July TPOXX XX last for health approximately XXXX, its are have $XX the key from very believe building people procurement $XX public XXXX governments jurisdictions across the million well orders and With outbreak, in approximately monkeypox the as from multitude international busy international to monkeypox of of XXXX. number TPOXX relationships. XX X public responding orders the jurisdictions TPOXX to jurisdictions ordered first-time XX customers year. in the of and oral with addition approximately number a this significant oral the existing that of continuing of procurement inquiries increasing TPOXX year days, X increase

become. the Right community use of early baseball and family. of analogy. is that concern protect early cases what highlight innings appears grown sheer such potential. to stage, a than public global to across Based more health The risk the orthopoxvirus And expanding. we now, is XX,XXX order and following risks by is usage outbreak, ultimate could to of to respect program inquiries proactive the any scope and monkeypox the to reports to health in much number cases the to serious on outbreak, seriousness of are cases its magnitude approach there of learned for threats. inquiries With essential orthopoxvirus reinforces of the posed the as the component it and designation Firstly, has monkeypox the outbreak a monkeypox a designated and more of and health far, expect we've significant TPOXX governments such what viruses what to the addressing we in to international both of that come. emergency to the to the and with the public believe At the robust frenetic so that the currently world health secondly, outbreak we in oftentimes as of outbreak The regard that manner of have scale a against more spot recent the the this anecdotal of adopt breadth WHO a the requests learn Monkeypox get public be is transmission quickly families are same nature clear. better the as of sense to

of is hospitalization have antiviral and severe the not severe is significant have reports clear therapy a monkeypox case infection manage an Patients available. to patient the and scarring stories as pain, when made First, disease disease experiencing can are consequences. complications

weeks require with a family on or X or members. quarantines significant who Second, that impact work cannot have patients interact more

highlighted orthopoxvirus TPOXX. Procurement for an too to after building is do ongoing And sum, to this virus for outbreak. of other outbreak cases to real-life having In has of Fourth, of and the call require and address networks outbreak vaccines the governments hesitancy spread expanding governments we governments monkeypox the vaccination stockpiles social and of and treatment the the to alone smallpox likely be men to words, outbreak. both of pace and are this to challenges, In this of outbreak will none the sixth, population takes monkeypox the exist will the to where segments clearing stockpiles MSM mitigate needs examples exist. that and impact to the most Fifth, in by men the focused the sex a mitigate believe variety stockpiling is currently importance able community, it or outbreak with anticipate a limited experts do cannot the the better resize although Third, access increase growing. access not be drug. vaccine to of impact. population. long Supply TPOXX of

As and/or become endemic. such, regions in activity countries partner, Technologies, pursue with Meridian procurement promotion to grow monkeypox coordination international tangible and which we will Medical continue continues in in to

for planned being being trials is to us is point enroll addition been and get TPOXX. opportunities monkeypox from In catalyst way procurement the and trials as a Monkeypox international key one for collecting also patients catalyst is population the from approval to usage a orders, outbreak better to access with patients. pursue important for This because to has data for we for the a monkeypox TPOXX in focus FDA, which oral

of efficacy opportunities the Dennis monkeypox will indication. TPOXX for it has FDA in minutes. the wants a full U.S. the in in indicated for monkeypox the approval few of the background, treatment discuss As data that trial

the the touch call over hand on would few months. I a Dennis, over like achievements to series to of past I Before

On And Healthcare United the and was regulatory approved July Medicines Agency, IV in FDA the the the by Regulatory MHRA, formulation May. in TPOXX Products of was Kingdom. TPOXX approved front, by the oral in

span achieved regulatory the a TPOXX a X approvals for in year. With have of approvals, more these half approximate little than we now

oral the for TPOXX complications labeling smallpox. The cowpox EMA Agency, other use I EMA, indicating note Health regulatory vaccination will in following and approval approval its TPOXX the Canada December monkeypox, vaccinia and approvals against Medicines of include January that by European being smallpox, in the for approvals and oral XXXX. MHRA the broad treatment

All with studies protected consistent a in the safety of showed efficacy in conducted data published regulatory Medicine primate. model. XXXX that the by death over based Those clinical on approvals to trials New in Dennis and from protection with challenge lethal XX% levels these of pharmacokinetics were animal human Journal England demonstrate nonhuman

reduced During setting. trials whether use humans. they collect or an We These outbreak, believe the a broader stopped to shedding. the presenting for these always smallpox data are will of planned TPOXX update an showed in we support Dennis for primates focused important with on being or confirmatory disease will on approval to collecting data. use ongoing provide The in outpatient of progression as efficacy a set the clinical are and monkeypox, studies the nonhuman TPOXX with in provide wider data treatment of and treat broader the basis TPOXX for patients clinical infection. U.S. of trials in the viral anticipated monkeypox

we be for the and other procurement TPOXX, half likely XXXX. in $X.X which for our expect exercised Defense On approximately contract million option was May. Department the quarter procurement procurement of we first contract front, oral the signed to the is in with The half in U.S. the second of of delivered approximately

important that add to opportunities is our be to base. to expand procurement continues this way it will there believe revenue we is procurement. this One Additionally,

I'd quarter we over the for a will of to point, deliveries when made the intravenous U.S. clinical program. R&D update PEP our Dennis? As TPOXX At first details our regulatory hand Dennis including provide Hruby, reminder, the in this the revenue government. who a to first like base expanded on call and

Dennis Hruby

working comment with an comments my start and will colleagues trials. X clinical I regulatory with the on trials With approval on trials clinical connection the PEP or update TPOXX the treatment to post-exposure TPOXX I Phil. will PEP, with you, DoD then our needed oral Thank in postexposure respect to outbreak executing of prophylaxis, a of monkeypox reminder, on And for monkeypox. prophylaxis. as we're support

set study, off X I safety the sites substantial as strong and these and to being the clinical For around expanded U.S., dosing mid-quarter. sites up characterize enrollment have began start. would we

completed been XX-day most end approximately the the the of period. had dosing July, As study with enrollees of enrolled having half

plus vaccine to This was TPOXX slow immunogenicity volunteers. recruiting Jynneos started screening XXXX in trial, early sites we X in with a the This other the the trial U.S., enrollment. of speed we've among and other due in post to and start. protocol off In coordination got factors. made hesitancy the COVID For adjustments have DoD, to adjustments normalize and part enrollment so as

of improve. past Over has foothold before series weeks, a the in to gained monkeypox U.S., outbreak the substantial begun even enrollment the

to outbreak, monkeypox to we're in trial. this the work further enhance continuing With enrollment

have activity the the the the volunteers studies, now the regulatory the requesting package I'd by fourth expected would for of in results, showed oral for XXXX goal Shifting to phase all in TPOXX a TPOXX both commence clinical PEP. If quarter For connection late like monkeypox. gears, activities is assembly active the study with in or early in of we to third quarter. complete approval discuss

are trials We with clinical assess include human placebo-controlled to in as effectiveness the of as launching and/or and up Africa, prevent to and to clinical patients. trials. supporting TPOXX formally in XX both monkeypox well research assisting currently North studies America Europe These multinational treat observational

as a U.S. launching facilitate these quickly drug need The to potential those indication the of support speak, accrue who hope here data to of I first in we and getting is to to monkeypox it. approval

previously Dan, treatment I'd in highlight TPOXX the being something calls like the orthopox approach. and wisdom by the which of earlier lens been turn believe to we And outbreak Before through Phil, investor we of for the I the is shows of family that's this mentioned viruses. monkeypox call today to think of that over a

will look our turn of partners indications update, possible. As pursuit Dan. for call that government to label over and I'll With such, whenever continue TPOXX opportunities we with work the in broad for to

Daniel Luckshire

Dennis. Thanks,

and revenue months $XX million, $XX June XX, For is X million the respectively. approximately ended XXXX, SIGA's and X

U.S. development research with relates $X sales sales the new both quarter, million were TPOXX. oral TPOXX the $X Department For activity. of connection TPOXX, customer. to relates revenue Approximately to In oral approximately sales to sales the the million and Defense of a first-time of remainder to to and of cases second relates of international oral

interest to ended the and June months TPOXX X XX, excludes to Department ended approximately to was of the of XX, $X.X to international million which fair Operating for income, relates and the sales sales value Defense relates activity. the $X of X taxes June U.S. remainder the and intravenous income, warrant the related approximately aforementioned the new of million revenue to the jurisdiction million XXXX. Approximately the adjustments and government. $X development For to months research

operating for For June $X the approximately was X X million. million. was ended ended XXXX, XX, June months $X.X income approximately months XX, Net the income

per $X.XX income the income X the June turn, was In balance company months XX, for For million. ended diluted share. the At $X.X XX, June approximately X for XXXX, $XXX approximately diluted fully X months per And the the fully ended June months was $X.XX. share share million. June was cash XX, for ended XX, net income per XXXX, was

During and cash the second quarter, SIGA paid per dividend of share. special $X.XX declared a

shares million. Additionally, the company stock for approximately repurchased common $X.X million of X.X approximately its

of addition $X as management orders of in XXXX build approximately will for fulfilled work in note million remaining be XXXX. received of This cash point, of special please international million turn to use of October XXXX, reminder, cash the delivered XX, to this With these and $XX cash expect is call as second to we delivered ingredient. I quick such back Phil. quarter expected orders XXXX. for a process that the to financial repurchases, July inventory Approximately As XX, quarter be million between pharmaceutical the At X, the activities $XX and expected the in to in concludes share July proactively to and active year capital are this respect the the third orders using dividend update. to were

Phillip Gomez

Dan. Thanks,

growth points, streams like results Before ordered offers significant few financial product viewed initiatives to the of made that delivered been have by an in which complemented many is strong attractive to our that past of would when collectively. in that I view existing generate potential we turn Q&A, and organic of a revenue hold SIGA when support combination reiterate

TPOXX that that to the being U.S., and the leading heightened that I'd many only outbreak Canada, understanding in Asia reiterate monkeypox the used region, countries, connection Africa monkeypox. or areas. to the used is expected like is with the in of therapeutic likely Europe, be treatment First, importance TPOXX other is Pacific has and of in It our

work provide to community the continue will TPOXX to medical We pursue appropriate levels monkeypox of with governments to and patients stockpile. various to and

countries, manner. hard is a Second, and the expand We including to that now value-creating than ordered I sales highlight TPOXX, we base. that ongoing to in have would more work like continue the XX international growth have U.S. to initiative progressing that

as this factors, is uneven lumpy international gradually expected market meaningful many given variety front believe shape. While be is times before, to progress that on of and we noted a taking

Third, any stockpile the represents program growth I want reiterate for that regulatory that development it a support PEP-based scientific provide would initiative expansion. to in and

As reinforced of the by the health a our deliveries, transitioning year, be TPOXX stockpile and we Six, can financial U.S. new need size pandemic, well need portfolio virus of oncology becoming stated and TPOXX. international scenarios. open lesson current diversified. we for This will from and of care the of being added critical governments monkeypox pursue on family. with be we outbreak our collaborations is from is and predictability. U.S. to who earlier contract customers as in the list our associated Fourth, well annual to to is as Fifth, proactive which the calls, on that supply the continue more to social customer up the that contract A not strategies the support outbreak jurisdictions. that we to risk be TPOXX as believe as SNS focused appropriate smoothing chain would be those Defense treat many for requirements COVID all planning sufficient in to addressing which Department other size markets long-term stockpile on more continue to X focuses

creation. believe This prepared our the potential significant we and these will remarks, session. we concludes have now As for begin when mentioned value collectively, viewed earlier, Q&A initiatives,

Operator

Instructions]. [Operator

comes question Romanoff from first Edison Soo Our with Group.

Soo Romanoff

in because guidance penetration restrictions your there is of U.S., chain Or predict most you some the Great. model anticipated stockpiles. easy against is the give ability your on -- the thing interesting The supply pretty is us state. is any mainly Could to revenues rates? pretty

Phillip Gomez

question. your for much so Thanks

in X.X the there course is U.S., you As stockpile. a highlight, million

case We likely availability it is the of evolving of inadequate program outbreak, size be would stockpile have our rapidly question the in discussed smallpox label that circumstances. that, it. the that is post-exposure set increase add to and pointed a and out very of that a internationally, of looking the and To to

driving So outbreak our would we're be I there's X say, will goes today, are that things the performance really it that that and reporting forward.

monkeypox approach, There organizations around think world was think of even a part a lot bit first public of came. So as threat is, was of the did the I unfortunate. a first not unfortunately, when the limited health statements lot of a morbidity, a serious which and wait-and-see cases around limited mortality

mechanisms governments For countries have those I'm place it, to deliver. very have go process. also procurement we did the through procurement us We that X excited. pursue in that for now to have

to also the We cases have them do follow-on have are on see immediate initial that for make We of they activity had which people in usually orders, orders. based the But area. increase. we have number do ability now

the to in declaration needed help outbreak. officials focus will to be along on going public of health the emergency what public with the product health this delivery mitigate declaration is I U.S., WHO's for think the

and And to the by so we execute stand orders ready deliver. those

U.S.-based a side, of we supply comments been there. strategic had years. there that we U.S. and approval. XXXX knew since XXX,XXX in courses expiring the XXX,XXX over stockpile had And the those couple We the to have the be that supply On in not know, may know We U.S., next product delivering has that courses would XXXX. XXXX. We for few European delivered chain national a

not our fixed a the with but a above existing that we network course XXX,XXX courses, the campaign to product. It year our CMOs their around XXX,XXX capacity of mark, a have So above ceiling. is it ability certainly network existing get is and the certainly

ways working So we outbreak have may to busy U.S. address been about ultimately thinking increase with ways find go. that the government in the wherever and production it to

in certainly, The So that a is there. stay warehouse. tuned that do is product have line bottom we

made. get that orders against shipping are We

so in least good point the in outbreak. this And position, like a we feel at at we're

certainly the depend number to and course, for scenarios but at will Of looking number we're see that that. of we that globally, ultimately the cases on plan courses of

thank Soo. So you,

Soo Romanoff

the positive you're One Yes. getting if question. any you Where monkeypox, it I with was -- here approval news curious that? some think U.S. like are directionally, of idea but had we for timing more I seems on

Phillip Gomez

there? probably think Just do Soo, about you're patients. I'll innings. I to have Dennis. data Maybe to asking over It's it clarify, comment efficacy early any Dennis, you in hand But

Dennis Hruby

efficacy for FDA to safety clinical trials Yes. demonstrate before The would controlled they has asked grant consistently approval. monkeypox and

number As standing you've in of trials the are globe. of probably process a seen, the around up we

network. U.S. the the There's Canada. months. these And over one endpoints. in U.K., in clinical in are next be there the same and the All the the there's one same is essentially few coming trials with of in one matter using out that should Importantly, the data protocols

So we'll apply for here U.S. in for to position as the that be data think an accumulates, I monkeypox approval in a

Phillip Gomez

Soo. you, Thank

I a think important approval access label second One for patients is in is the that full outbreak. divide X then it's expansion by points. FDA, approval ultimate for And an an important to also provides one monkeypox.

Tony As we've would in to available out to been that. of any to been studies, the infection. will seen, immediately. appropriate health that ways access like CDC as think to around a help of data to complexity do there's pressure said ongoing We've to access reduce it and But paperwork community, FDA continue what's certainly get emergency they're understand certainly health certainly, the the this expanded request on has And to those been put supportive to the public call said getting to the that IND. drug continue respond to for very see Fauci I the looking in FDA from from today clinical I declaration the find would burden need know folks to physicians. eliminated. he that And has drug the And with trying challenge would a interview monkeypox in an public

As knew on be is we said, that confirmatory go we we data always but that likely know efficacy based data get back the humans, efficacy I would positive. is to in and data animal

make have important that with front today work So and get suffering CDC And are have we're declaration access folks it's who patients. progress FDA important infection to FDA and CDC. that and clearly, and doing, we'll continue the access. It's to the on get Thanks. to to at -- encouraged the

Operator

StoryTrading. question comes from with Ben Our next

Unidentified Analyst

off I versus give don't of can beginning noticed you this. in I that government. opportunity, Q&A, over you the got in with the so million at of if an XX with sales guess, XXX monkeypox sales. I covered you cut months the smallpox for I QX, know But X federal idea to contract next the me did

is you? bigger for where the So opportunity

Phillip Gomez

a question, it's for Yes, Ben, and great it. you thank asking

our our of is you story to delivered may So of a for a has The be the those revenues that's It shelf current to in X-year the life. U.S. be XXXX. on new stockpile that government. started resupply in product

with associated options So we with are government. that. resupply there U.S. lumpy started to the And

roughly X million $XXX.X and that have XXXX orders we So come that we anticipate XXXX. between would

So orders that X had XXXX, in delivered. be and we XXXX would

we of anticipate As do on previous year. expiries we've high a said this number calls, not

couple after in thinking studies scenario think The It's planning be soon focus as monkeypox using use being closely. starting now We a the many things outbreak anticipate possible, it to Obviously, it's that. government. is the deliveries on and reiterate next used the that is we get ultimately those the as Ben, I'd -- monitoring to have and will an What excellent are impact but of the outpatients. would question that is So on think of one. monkeypox it forward it. innings. We're around the designed up how maybe outbreak we and and important about to smallpox that the deliveries front are U.S. people could your manufacture placebo-controlled Dennis would is U.S. as we early could government. and then say the similar on drug. that drug the for hand year the year I

get will diagnosed treated, just not severe phase the disease who course. So the get disease people of

or stay to going we think endemic we're be do carefully. in and that say regions. this is what closely what be smaller and and to we some a market market. So the if unfortunately we're monitoring But family But become than might current this it of the opportunity be But will smallpox ultimately monitor I is viruses. what will can here think virus larger

to it's perspective critical the available. important be, whether smallpox, whether monkeypox, has And whether antiviral XX% I don't whatever clade that these to up been know African to so might on Central in is monkeypox shown to it had remember of Dennis, be you are fatal, the have it's what is types on of drugs anything outbreak. your it's if

Dennis Hruby

most No, agree monkeypox I stay. here is agree, to and experts that

to I diagnostics its others. burden currently incubation period starting children underestimating population is much how think because of prolonged see current and and We're to spread also deaths. from into in the disease starting the we're We're there delay some virus. the see of MSM

think I going problem period it's be is away to go this to going a significant of and for not time. a significant So

Unidentified Analyst

I Great. wanted make to correctly. I heard just you sure

but million the or talking this expect about said $XXX like you're so? sized You similar order year, year, from government, in XXXX, like a next you'd not

Phillip Gomez

there anticipate be that remaining on in executed our Each XXXX XXXX, X XXXX That we are those and In million. or is $XXX.X correct. existing essentially of and orders XXXX. options will contract

Unidentified Analyst

Stock Okay. quite up Great. bit. around Last repurchases. question. I share is wanted is thinking what the to your a know

So how can that going of to company? about value Or the the we levels, think at forward continue? you these expect do

Phillip Gomez

Yes. I'd say we of about of have have like I disciplined record very we that our -- that to being cash. a use track would say

$XX a over special in done dividend. we've share years, repurchases. million $X.XX did We several past the Over

to to that from basis. it on We've business, outbreak have look bolt could the on is all going whether where be cash uses accretive cash -- where but make our past we're could a to on has clarity certainly to disciplined a as go. in potential acquisitions of we scenarios lot we do to sure continue that been cash, returning at We M&A This shareholders. focused of

share look So best we to continue understanding will But the to and dividends, continue right look still cash. continue now, certainly, outbreak where look this at of to at use repurchases, ultimately the we're goes. at

at to certainly continue we'll So it. look

Operator

comes [indiscernible]. Our question next with from William

Unidentified Analyst

you a might please them? had of I if question your or Nordic over I have Bavarian guys And is confirm did edge about bit what this competitor research. little and correct not, a

are guys approval the awaiting You still they occurred. sure FDA while already I'm FDA for vaccine, not that monkeypox when approved. are

Phillip Gomez

Sure.

So thanks the for question.

Nordic XXXX a vaccine. monkeypox So Bavarian that has It was approval approved, I smallpox. in included believe, and

to a treatment be We're to So for it. the to of given against apply intended the negotiation response of approved drug. the pre-exposure and to the immune only get We smallpox. end create that's for of antiviral We vaccinia. in smallpox. indication vaccinate someone at did FDA day, to a XXXX the monkeypox, vaccine and protect smallpox, cowpox approval broader for actually And the U.S. an was were

and is U.K. at gave same data treatment reviews, well to smallpox. U.S. was In as approval the the looked to also There for mentioned. and get we data mention was monkeypox. the the stockpile being Europe are X.X approval approved to us used used I'd EA a but the currently just thing that outbreak process the are is for approved drug through one I an in that opportunity million not drug The we're So this monkeypox that courses submitted IND the that also and take in their they as in

safety based So data human the on that data. and animal then the was done

question. for you your thank So

Operator

Our comes next Brian . question from with Adams

Unidentified Analyst

questions. quick A couple of

like be from meet you international then get demand if and/or weeks. price. And of As that buyer? how look I've believe, dose, does What the structure pricing far you expand $XXX read, Europe? in like a America supplier? per dose from I several upon order course, as and Would per large is dose, -- there international could it's it you out of the what quickly were South what that? that I with can $XXX looks over same an to if But share a to your

Phillip Gomez

I appreciate that.

talk pricing we volume But about slow. So the too government in the the contracts, the don't Canadian pricing and contracts U.S. specifically. and is

U.S., $XXX I say, course. high sell level, at So can, we $XXX in between a a the or

for million government treat XX $XXX on drug course was our it between X.X buy based is to and stockpile someone in for volume. that's volume. And factors paid $X,XXX. high In lower enough that's and when Canada, They days. they the So have that U.S. the Canada, at development of a number

pricing negotiated with It And channel. through the commercial so government. doesn't our is directly traditional go sales

So the that, including is we We've that sales, filings that margins is associated in margin, sale with Meridian our so associated government. in in filings. commented the paid to international the directly around fees including with the that available our

Unidentified Analyst

And also America? quickly how then far South Western you on as large a just or follow-up as Okay. order a Europe meet can

Phillip Gomez

Yes.

how large orders as ready So will It really work of to along. on Certainly of product on those whether believe large is able or we be it to depends now, come in that we inventory, with how large. deliver tens But out product have progress available. moving use we'll current anticipated, and right We're orders we that's that depend the to of thousands inventory. courses, in we deliver. have

Operator

Our Peter Point with from North is Imber next Partners. question

Peter Imber

respect for monkeypox one monkeypox, is -- you've regard for have provide just think commentary can with tests far, recent adverse there done more the formal around significant to additional of that comments a effects? with from first to of And they there in If one read of approval. Journal I've mentioned The articles, is, couple so, some want that? I so sort there what cited they was to wondering, you TPOXX any have to give sort been of all testing I do New a some effects. adverse Is Medicine a England they that FDA looking been?

Phillip Gomez

Sure.

So defer our in Dennis, to describe support licensure. clinical to you studies I'll of

Dennis Hruby

studies Yes. had typically that rate no headache SAEs We've see Thus placebo. or same the occur few The in AEs. is about in very and far, TPOXX is but drug. safe very the clinical they typically we experience diarrhea, our our a AEs are

seeing So any profile. we don't real anticipate effect side

Peter Imber

other direct versus drug question, a given applications the this slightly anticipate typically my do then That's helpful. of it's path. you been of governments? selling this, sort different commercially And But different to

Phillip Gomez

great be it's to Yes, ability we're launch to And able the examining working certainly, on a that question. and commercially. it

through one As by that you become initially this. in the be the sales would outbreak historically was been But said, might event patients. the outbreak now Tamiflu was U.S. been government, a also right the done hybrids pandemic, an U.S., of the channel commercial market. drug as COVID an have deployed. that's sold over the for it There's the just the traditional expectation therapies the bought more in And government influenza be commercial, would like would were stockpiled by like that, in stockpiled but to to years. be that how go progresses, ultimately, it's that sold And it accent endemic. being U.S. also has of they that scenario

launch the data where the doing continues. to look and that by we're it that in outbreak FDA now be We what ultimately, But might for planning have now important around and as the as like and humans efficacy the driven be virus distribution. analysis will commercial will So a the that, to lands full that that. approvals for think really

Operator

with Investment. Our Strunk next question Strunk comes from Todd

Unidentified Analyst

one that, the been or on initial an I visibility provide some becoming conversion about customers. about ask it a you conversations And commitment that Could wanted questions couple order of on job the please. jurisdictions look? new whether are you stockpile? like what Great does call. a the to to be How are that

Phillip Gomez

Sure.

as discussions most get are the say of all possible. fast would to product I current new around trying outbreak So and jurisdiction those to countries the as

a we how small permanent we amount in do and -- contract import, supply we how be to vehicle how tend all they chain here, place, do get regulatory a the small do understand get So relatively that.

asked, and talk we be I discussion do hope, to turn there -- this the do where tends we we've start countries say could for conversation monkeypox. anticipate we it term, discussions that will in can So is disclose. We individual it outbreak countries. And that, to amount the compared an have around do long stockpiling. broader ask about we stockpiling. been think around they if to right do get We historic will then after how accelerated ultimately, do a deliveries to into what we then phase

gotten pooled were ongoing with we have under countries those in and with the But Health region tecovirimat. to is We are countries America Pacific in interest announced Commission in that also the American geographies. several new are the not that's authorization to is agencies response, Canada. the certainly Europe countries Europe. they're procurement We that. said due also reports Pan has which of We've the HERA, the organization in There in well. be that Central confidentiality in certainly able South reported and has there as say what exception Asia had conversations been Organization certainly interested looks European with

have need because they we sometimes it individual So conversations faster. countries with

see pooled multiple with conversations that efficient pooled have do to agencies We if way procurement to there's better get procurements. access regions a for

Unidentified Analyst

got stockpile in what And of or and order X that to you partners that you've based further what already look do mentioned point procure. on question to other having warehouse, in need secondary expanding at Great. just to towards earlier you is,

$XXX,XXX, $X visibility meet $XX needed? some what's might And million, massive and it at around million? partner So how if around demand, is you

Phillip Gomez

Yes.

So there's answer. layers to that many certainly

and our to As if we courses we partners and their that facilities. get current performance can current prioritization year. those can get I there We scheduling with of kind this, well a was north of think of XXX,XXX of up mentioned, a

the We've We of in key ingredient, that components a also been have second on of from of which development active develop site support one that. BARDA, pharmaceutical to is parallel. working

goes but that that's could come on, away, online. be bring another time So a that to one accelerated little ways online it's would that as

through a the is is government we're goes, good about but scalable. of where demand with scenarios. certainly our is the really supply robust chain the U.S.-based question ultimately this It and working U.S. the those in thought So partners news has COVID. And

to partner look we to we so them about a be think this good as And scale-up in option.

from and calls about are Investments. opportunities what's could We thinking had Chris broadly. be there best is even way certainly the that, question Beyond internationally. more inbound Operator to Our next scale [indiscernible] certainly

Unidentified Analyst

sort looking be if course? about here? well. at to few was what's out per then So about sold international TPOXX number both And And thinking potential on of what to a should good relative a I the build how that ballpark guess others have any is model U.S. sales, as a the there I price you've think I captures to and that upside I historically?

Phillip Gomez

Yes.

mentioned, don't with we do stockpiling disclosed, partner. as future, know, at government component. U.S. as if So say Dan, And customer have I then any long-term think we the an look on overview a as would I of you an important give there's to we want that. I the And

comments Dan, partners So if be and in our in there. any deliver. information want refer to this is have. you to we have consistent certainly pricing we have the we something be don't other But run, on to can that able long you financials, want But that and availability to I know

Daniel Luckshire

Right.

of safe In of think it $XXX partly you'd that the -- the the $X,XXX. And country. to side, between different other use. U.S. be So oral financials low of is history financials you'd be for the factors. individual I from refer those for numbers the and a north size potential range $XXX number Canada, the small I a And through is on $X,XXX, be government it a the and would see higher to Phil the use as to because the of number essentially function highlight higher will that range. series the broadly. might for U.S. been disclosed each TPOXX then would be I of mentioned that. the has what the for and around for The previously, $XXX numbers order. IV, the you that Internationally, can slightly than see the the that was order, it's that could pricing bigger

Unidentified Analyst

Okay. U.S. additional I Great. declaration, up federal asking free guess emergency the federal to funding. And presumably government some with

BARDA? sort think any any potential either that CapEx then about, I with about, order may accelerate, here event margins from working directly the to company with on you're how be guess, to about may that cost you about expenses Is continues of spend. is guess, that substantial when the forward potentially ramp amount or think outbreak we I the so meet to that we Is that And we be a either company the potential to we in there thinking of in And access come thinking the How how it funding, going and to offset the that? government? dollars some to CMOs should have through with should production have opportunity should to that or this of incur volume.

Phillip Gomez

the the comment model. on scalability our CapEx on for Dan need your question around of potential have I'll declaration. But and emergency So the

So response it's government. the that frees up within more some but U.S. the funding, details of

I think procurement the orders. more important beyond thing for thinking the opportunities about

about procurement that about the a talked been Congress dollars drugs provides billion like But $XXX has orders the come need, $X about procuring a used likely with over if Biden things when variety, I thinking a for about administration think accelerating years. next wide then in have that that will stockpile looks believe some has And ramping outbreak, administration the million potentially in U.S. few about number sort like at government remaining Historically, the that an through a of appropriation. appropriation. a including size, appropriation reported, up, them or the there's them We update. supplemental we a different is ours.

be where challenges with certainly probably scalability want public the about supplemental in health seeing would a of any would with to up. supportive we're what do the talk appropriation, of that Dan, you the declaration to but show the would the plans that contracting provide the around model? our that's operating But So change change We're material material outbreak.

Daniel Luckshire

scalable. Yes. the a -- fact function that historically, outsource very we It's really supply believe we a very of and going very forward, It's historically our chain.

chain. U.S.-based mentioned, As Phil supply the

continue outsourcing, at -- monkeypox that on at has look given we forward to you anticipate scenarios. to so side. continue big our CapEx moment. foresee now, be would to with minimal, So we been look at Granted, there continue the the outbreak, production at side, look on the different really we if many any and financials, our going the are CapEx right CapEx don't it. We'll But the low

Unidentified Analyst

question for Great. Okay. me. last And

data, file if the between be guess able when approval be data then outbreak the when you'd positive will file potentially there acceleration and would in you So supplemental that label the presuming able be this would be you get happen line when for I when I the time for you what that trial clinical imagine continues to to to for some the may then would you'd U.S. the anticipate would reviewed. worsen. be could be the

Phillip Gomez

Yes.

Group, network. good that AIDS together. trials which They the the all doing FDA SIGA, be clinical is -- and NIAID, is news think there are Trials will I Clinicals NIH, working So ACTG, the they the the

clinical anticipate, was to and its drug more is it large of it will the be the going to will as EUA, that generated, we enrolled that predict and way be or data, criticality made before enrollment of hard and up, sent rapid it's on reviews if available the of the acceleration an outbreak certainly us mean -- anticipate patients hard So final And be getting trajectory under or review. approval a the it's will both question, an to can rapidly trial, there the final patients timing. data is to of your to is the number after predict could whether of middle it rapid it because access also the drive -- FDA. But to is we because one, continues, do expanded if two, a that based

parts So see of right to at quite out least as start trials soon, and fall, hard predict coming expect we all studies. data get to the said, it's do start think variables. we we'll those given those But the now, those of we initial Dennis into really as to

is it rapidly. progressing So

Operator

question-and-answer the over comments. closing We end for have like Phil to to now Gomez back session. reached the I'd the of turn call

Phillip Gomez

join with to end like call. been deliver has have and drug like really and years I'd shareholders. drug the that to to get just thanking and there. done. a of We results a The wanted large health, So with of We working need for some thing And partnership. and TPOXX ASPR here last today's that U.S. translate creation people to and that a on approved. initial there at need number this NIH working out taking look I'd go. human U.S. gets thank get value these got lot for time impact the been sure that this around SIGA drug the to this my clinical access partnership to a government. great great working requests over we We've great get there, government a thank ways I it's is for we a I BARDA and pride trials at by our partners is of everybody to point. the to out But to think forward clock, just us our who to SIGA, responding we to that come do on history with working here the to all see into making of the and great to colleagues everybody for

your Thank appreciate today. much. time I so So you

Operator

today. call the you Thank for all joining

contact of release. investor any concludes press information conference. the If bottom find questions, you have additional This you today's can SIGA's at today's

this You for may disconnect participation. your time, and at you we your thank lines

SIGA (SIGA) 7 Aug 222022 Q2 Earnings call transcript