Earnings call transcript Q1 2023

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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 statements to reflect events or change 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 31, 2022, and its subsequent report on Form 10-Q and Form 8-K.

Phil Gomez

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

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

inventory With our been Strategic the streak anticipation expect of a National in continue XXXX, Stockpile of that oral proactively of driver. to company's with performance being call, deliveries the substantial noted this financial TPOXX a On have replenishment last TPOXX in oral we building Strategic expectation, we we positive Stockpile. to National of key the order for

occur on approximately the contract. considerations, $XXX Based to current we XXXX oral of targeting would TPOXX deliveries for stockpile. of under series million national the XXC are a strategic currently deliveries These

million targeting XXXX. of TPOXX are Defense Department deliveries U.S. we approximately to of oral the Additionally, for $XX

million in as government of to the as in also TPOXX. European oral towards to effort, international addition work pursuing in generating of Furthermore, countries sales TPOXX from there March of deliveries the U.S. will commitment we XX, as oral to XXXX, for well delivery continue the of National With Stockpile from IV revenues TPOXX, generating international sales XXXX Strategic to were $X two TPOXX. respect approximately firm sales of of oral orders XXXX

the to on to In sum, amount. build this we progresses. international are we add the to active engaged currently work continue to Additionally, base year hard negotiation in will as XXXX

the for TPOXX. I the to eye two two to and progress call monkeypox discuss point, clinical on key program will initiatives. towards initiatives: to oral two, the an over growth, observational make this important turn Dennis With one, trials; these At continue we PET

Dennis Hruby

Thanks, Phil.

the XXXX TPOXX the outbreak. than respect government has or public compassionately use cases response as component to of trials has health are internationally. an trials by in to the five as of treat which have placebo-controlled U.S. TPOXX Nine randomized agencies TPOXX been global cases more to been Mpox the been Mpox, NGOs. clinical sponsored many for to essential used study of launched Mpox, With well are that

To-date, been trials. have patients these XXX more enrolled than Mpox in

series the that to ebbed the officials. a While the over an clinical there section last been trials monitor of U.S., cases months we enroll Mpox a cross some in Mpox continue in locations, have has the It's of government available. they cases in will as of noting worth to number with continue uptick in global become development consultation patients

Hence, we depend calls of would I These the the said what investor trials. factors especially outbreak currently placebo-controlled to Mpox number the with on be on in speed timing ultimate like randomized prior reiterate levels path participants and unknown. Overall, connection the of the enrollment the of the ultimate and to will likely timing, the the general the trials, continues trials of of enrollment.

counts last whether hemisphere For in the will count in mirror Mpox the to predicted. year example, case be has Mpox months as any roughly the of case type remains summer coming to it over the be seen increase spike northern CDC there

unknown to remains factors, composition be submission given determined. label the such, currently and for for an As an the Mpox TPOXX of FDA timing

sufficient with are contemplating regulatory That of as the to subject various unblended note said, for that it's the data of evaluation. it numbers idea encouraging RCTs is their an reaching aggregation potentially

It's scenarios, periodically. We cases there cases, levels whether countries will and outbreak the become and and and across cases will of we date a in come the what path the consistent United in have the have of to across scope high with case learned Mpox future to of States communities there's as uncertain, or other for most a short-term TPOXX. is deal world unknown the probability that levels different to just Mpox the be go indicates whether While the ultimate magnitude believe seen years. need case that

I'm I company program immunogenicity recently for provide report gears, TPOXX. expansion would and that to Shifting trial. trial like to targets happy has expanded an PEP met the enrollment on the both safety oral for update the the label

As plus safety reminder, safety with a as of XX-day the Jynneos over oral TPOXX vaccination, the oral while to Jynneos' test TPOXX PEP test trial TPOXX regimen. a the whether quick immunogenicity expanded subjects interferes trial

days. analyzed treatment being In for oral trials. contrast, Samples are the both XX TPOXX for indication is currently

unblended results to according occur schedule. both goes for days within everything next expect and trials We to if data the lock XX

of few program, I'd the for to and mortality experiments expect of supportive be TPOXX a TPOXX use and we the PEP use successful trials, on With previous like note reduce will orthopox Mpox Based case epidemic be both to smallpox, PEP things. the PEP. respect the morbidity and clinical in In or animal challenge for trials an virus important it be for the will population. of to

of submission. trials after be supportive next regulatory results a an from would preparation supplemental unblinded are step NDA commence The analysis for Provided the activities sample to submission.

we're XXXX. submission, such For targeting a early

point, like financial update. Dan the I turn would a this to for At to call over

Dan Luckshire

Dennis. Thanks,

to sale months which XXXX, the U.S. Defense. Department Defense For of of million, This third oral sale the March $X ended past biggest over the XX, revenue TPOXX of approximately oral of $X three XX relates the to Department the TPOXX of million approximately was is the to months.

first development the revenues primarily and to of activity. quarter research remainder The are related

Stockpile Department of of targeting of to oral Phil his $XXX the is on based change. and on to approximately considerations TPOXX Defense. U.S. For noted TPOXX are the as and company of XXXX, $XX year in a series the sales revenues sales Strategic of approximately on oral are These targets to by subject remarks, million revenues million of full the National

TPOXX. targets In an oral and in of addition the sales to the to under mentioned, XXC deliveries is IV option company strategic and pursuing stockpile also the international pursuing sales contract is of exercise TPOXX the just

provided XXXX markets. for and sales still not targets TPOXX international building IV details for these have are specific We because

efforts, two the for international the Phil of by call, delivery sales commitment TPOXX. of there in in with as XXXX March countries million noted at XXXX, the XX, European oral earlier orders approximately connection $X are firm In from

Additionally, negotiations engaged we currently in this active to amount. to are add

first Pretax during for income $X financial operating which diluted three loss taxes, $X.XX. three months months the ended March the the share loss XXXX, interest was results. and to approximately XX, Returning Net per million, quarter was and loss, XX, $X million excludes March fully ended was approximately XXXX.

balance company XX, March cash approximately the $XXX At for was XXXX, million. the

approximately approximately first the repurchased for X.X During million million. SIGA of $X.X common stock quarter, its shares

back the point, to This this will update. I At the concludes Phil. financial turn call

Phil Gomez

Thanks, Dan.

R&D financial updates earlier be highlight to special on on dividend in operational X, we a the XXXX, share to XX, I would will payable this discussed cash that call, $X.XX complement that and a based a a As announced XXXX. date like June record of have of May

on the use to can are continually shareholders. and return for disciplined best focused a background, As cash cash, evaluate deploy where it our of best we we process generate the long-term

of consider wide and a part process, range possibilities of of wide we a range As this consideration.

reflects this confidence sheet, a last special reflects business strong an the declare of financial time Time two, is in among comes a place and from the performance a years; forward. with; about optimism financial series going that balance to appropriate historical of The believe the action it we performance over cash dividend. and implementation is also solid considerations one,

of points to connection PEP the shift a I'd Q&A, we like to emphasize context in with couple Before program.

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

lesson those the size prior TPOXX in stated governments scenarios. addressing risks all to of of believe stockpile we calls, in COVID the Mpox associated the sufficient current U.S. by more the virus care proactive pandemic, on the As many A reinforced would from been be health which who and need would the not is be with to treat outbreak families. outbreak that in need has societal

higher financial on transitioning smoothing to of be Second, we to long-term annual a provide that degree contract which for the chain deliveries, a planning supply requirements U.S. SNS well the appropriate as stockpile be continue and as predictability. critical focuses contract on TPOXX size would our to focused

program, this long-term contract in want important that part clinical an I from mind, are results With believe the trial the highlight conversation. of especially we the PEP to trial immunogenicity

we This the will now remarks, and begin Q&A concludes session. prepared our

Operator

first Adam your McCarter state from Please Edison [Operator comes question. Instructions] Group. from question Our

Adam McCarter

SIGA Thanks that making. for the Hi. my taking about has question today. progress been like to I'd hear

a Just wanted the sort about to bit hear color little more orders. the international to just of know about little wanted mentioned you not a stockpiling. more around interest regarding bit getting the you're already just whether or I the --

PhilGomez

Adam. Sure,

question. So thanks for the

mix a the getting, I countries both on would countries on We mix they this making would conversation. are sure the that Mpox and based drug outbreak certainly to on up And of and existing board. continuing we'll year I say a see have are follow new say, of

I So build conversations. some new anticipate to would

conversations many have least studies. include to As to committing we've more We stockpile to talked smallpox that. had one an countries Mpox, before, certainly we've a and we also doing reflecting for initial of those those back that of smallpox encouraged. country because than thought like at it's We're have not about looks continue the been procurement

continues countries It's smallpox but able and time, still to it have about also be that of we're So process encouraged growing to talk number a as as evolve, well. talking discussions. a lot of over Dan we've a to seen said, as we starting slow to

Adam McCarter

follow just with another Fantastic. as Thank I And could question up you. if well.

Just monkeypox. those in if near placebo-controlled comes we just some expect coming you -- in wondering terms of on studies data of any out see in from when of When data our in can sort the studies to you guidance term? about sort give might

PhilGomez

this Yes, but substantially. I about case I ongoing, mean, have a bit. placebo-controlled a down levels have add come talked lot we studies can of Dennis little that

Although number that we of slowly cases a growing there. for in example, seen, Japan, are have there's

is parts spring So what I as case is increase two that we last line. load. did the cases. we think an there's the see One in of time driving If

are Europe, I placebo-controlled try the there and news that South U.S., Asia. studies in America, both think will those, is throughout the catch good world

of increase, But catch if work going be it's up to to that's the try done been we lot and a there's studies hard that. set to do caseload So see and don't those those.

data amongst in support try in part is, we to to We to the study mass. sure in as pool critical predominantly second places Oxford helped I data in to government and can go wait some have talk network U.K., to have, stock The be of that all which use to to approvals. is, get the and U.K. starting that, the to regulators WHO The the don't set clinical make are which has NIH groups, Europe. for think, governments, we also like whatever very studies for X U.S., able of They're Dennis University the highlighted, important.

see and tuned conversations been that have where encouraging, there's So that stay but are goes. we'll to

Adam McCarter

No Excellent. Thank much. from you very me. further questions

Operator

next comes [indiscernible] Please question your Investor. from question. state an Our

Unidentified Analyst

Hi, we've there My guys. could size years. the PEP is, program any last be? to this as you question around quantify this way Is for what been program the can of potential of several the kicking

Phil Gomez

hope I appreciate and Thanks, [Joaquin]. I in retirement you calling the appreciate well you, I all question. for is in.

answer for PEP is in that So couple of the implications a there's is XX-day treatment go very about thought would use treatment. a the to smallpox, that XX-day which we one you question, TPOXX for the that specifically from but a to ways of

amount need contract our million stockpile. to a the to those if And ability lot for drug course of the being you million requirement. maintain is would for the with people to double potential X.X wanted in Currently, the PEP, X.X treat of you a

very requirements what opportunity the U.S. So on that given the we've certainly, to are books, messaging government the is least, initial buys. already an potentially at had there's the double the

other time, following on and I than need and would one BARDA up to also add for have cited is very more those X.X that our been million of original in is, PEP a XXXX courses of reasons One XX kind long perspectives the of the contract that. you million. may in two they contemplated options, SIGA

numbers. potentially So there has been higher that even with of a evaluating long history

they for funding strategic national they stockpile stated in But the budget, the their like things including then multiyear buy. to would don't part have other repeatedly, all is full has the

a could that time. affordability certainly of lens over be there'll So evolve

So think we think an is the think to of ultimately that the think important we to should way long-term U.S. about doubling preparedness government it and the continue stockpile about do. the immediately

Unidentified Analyst

from it me. That's you. Thank

Phil Gomez

Thanks, Joaquin.

Operator

from comes question from state Weil next Please your question. Our Weil Instructions] Ralph [Operator Investments. R.

Ralph Weil

attacks, have emerging perhaps, one any again you and other bio-defense countermeasure the in involved other you for or -- Mpox, dividend the working are point the vaccine Thank you purchasing you at show diseases infectious I Are confidence actively attacks? this smallpox for and on for shares. special any question. in or besides

PhilGomez

Yes.

So Ralph, for thank you the question. very much

also do TPOXX that's our orthopox lead potential our We in sales. is have candidate As infection. you've far the is by preclinical product. heard, that product with a licensed treat product That to has

but We on. are very that, early it's doing work some on

say wouldn't box We have warning second always I know a black that So product one. two that's products. to want And government on had a was it. the the major licensed

to So products important we it's second-generation continue about to think there. think

in but then products, board. do potential we bring brought we assets. look be that those market We to would this at anything look And at on scan We to look board on countermeasures, for continue the have things And we potential. to date, not space at the science.

that's, not RFP and asset but could an help have. expect space a at have probably off things to We at that a continue RFP, partnership, we space products again, us we to next look actively commercial market. we after bring to look with a would on will the Cipla board government that's that that we to for BARDA monitor or the But they the an with at either further we antibiotic very and and that fiscal do antibiotic partnership have, bring the come year, little this go

question. So, thank for your you

Ralph Weil

for Thank that. you

Operator

At we no have questions. this further time,

Phil Gomez

at I'd to look value appreciate joining shareholders. time. thank like us support forward call. for our continue create to your appreciate to everybody and We We conference for first this quarter your

and day. So thank have you again, great a

Operator

This call. for attending. Thank concludes today's you conference

SIGA (SIGA) 4 May 232023 Q1 Earnings call transcript