SIGA - Earnings call transcript Q3 2021

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Operator

Greetings. 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 obligations to update publicly any forward-looking statement to reflect the 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 31, 2020, and its subsequent reports on Form 10-Q and Form 8-Q. to conference like host to now Mr. today, would turn over the your I Executive Officer. Chief Gomez, Phil Thank you.

You begin. may

Phillip Gomez

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

contract. this U.S. value $XXX provide To the significant We’re and connection deliveries targeted year-end, business, fourth are the third of In We’ll at be the quarter financial delivered opportunity questions. have XXC complete quarter, take we of cumulative In shareholders. R&D, by to government happy complete slots our stockpiled. with delivery a to will of option million. and pleased have the million toward to October, We where this transportation we this under a U.S. exercise, of to the manufacturing, locations multiple goal. in $XXX is then targeting have available BARDA oral million procurement to option update secure approximately to all had which TPOXX with exercise government $XX a we need would TPOXX TPOXX oral deliveries

extremely orders, to procurement and we we well international positioned disruptions are continue challenge, On delivery. the news, a have future the the team related Ingredient, domestic note, we do risks. are our and proactively ensure have Pharmaceutical ensure or in coordinating to supply-chain SIGA barriers manufacture ongoing all of API, Active for supply-chain is the a given be As to completing we to read working not hard or in delays

be options consideration prophylaxis the million National extension outbreak I’d and We for Stockpile. natural antibiotics stockpile COVID would Strategic size, care. that TPOXX smallpox TPOXX indication another is turn, nearly the government. stockpile the contract it courses the vaccines, includes remaining the a oral product not X.X to have the million. In each stockpile. to for in a options future value $XXX $XX If approximately million $XXX has procurement procurement U.S. these government. available options XXXX, total exercised that or be series for is exercise contract these This options which a X delivery Looking the X of are U.S. contract format beyond the contracts At intravenous exercised IV a longer-term in and XXC when then contract a years. procurement more approximately the options with to XXC by of the would expires, of TPOXX to used some and the courses talk development. the million stockpile could that over X treat would by we conversations the point replaced and stockpile amount million Such of contract is cover for if provide And government timeline. for be consistent under current Please $X U.S. other being transparent an product of U.S. expect next effective Shifting would respect like is the post-exposure highly therapeutics X.X contract the U.S. ongoing part those with contracted of of of smallpox our even sufficient to who need active reflect note TPOXX government to purchase our transitioned, that size, to gears be with believe slightly, about billion. products the could delivered XX-year during next of COVID-XX, with all years,

for be We year, with colleagues anticipate will it Cipla. now Cipla. calls, The to collaboration will have previous goal with for RFI antibiotics issue at Request is closely for not or fall, our RFP the next RFP was early track bio-threats continue but anticipated The has that to posted we issued. a and we last developed to As collaboration to the Information stockpile. and BARDA RFP described an on respond of yet

Given initiative this BARDA has related been delayed. that it’s the that is doing, surprising entirely COVID-XX not work

AMR, is focal BARDA believe at Resistance is a initiative when continuing the RFP issued. However, point Antimicrobial forward and the we or to we responding look

international in been the progress many a sales continued with delay on it’s but front, the areas, issuance. quarter target On contract

the pickup for the of this until $X.X the Canadian approval. as they And not side customers. we the ledger, seen meetings ahead quarter, military TPOXX oral Canada, with On to progress delivered we travel during anticipated Canada beyond and of Health after in would we option opportunities is have schedule a third which million exercise of

the With we at presented As a orders colleagues to toward the would continue SIGA to in XXXX. quarter initial foreign delay, the Medical new and the to from with conferences Technologies. by respect aforementioned order at in jurisdiction work and similar finalizing early be Meridian has of in continue Germany XX with our XXXX in such been the COVID an Canada The completion Italy this may Meridian received to impacted timing size order of be pandemic. and that

discussion sales advanced now as Asia. approval Middle the will clear patients, that countries EMA regulatory TPOXX optimistic the the customers detailed questions first stockpiled over conditions. terms extensive and who I’ll used that what there to update. country becoming provide to by Europe, as We future is call we requirements, it as product, and the the how product will be may and with an background, waivers Dennis? As remain immediately given R&D ordered Dennis, in import necessary, arise and will the time, logistics are for potential and pass that not East about be gain

Dennis Hruby

earlier-stage filings Thank you, Phil. advancing a team development very and SIGA has had directing The R&D regulatory activities. quarter, busy

filings regulatory on FDA. update is the an by application review in under NDA active TPOXX IV progress. The First,

to to unforeseen information any received delays, of are responding approval questions requested. XXXX. providing targeting be Barring we the quarter and are first during as We

guidance. also Rule And Animal Our smallpox. on as Health will Canada soon as following quarter Canada is Of review. XXXX. such, active the of note, treatment approval application come to under late FDA And could is of as approval restrict products fourth under Health of guidance the label

collaboration to is is first has the to advanced We’ve the responded quarter actively The MAA not waiting XXXX. well. objected as Thus our XXX-day for application being Finally, the and targeted EMA African far, treat questions the of trial, MAA patients. study Pasteur are SIGA support TPOXX EMA vaccinia, In clinical SIGA response. in the process for EMA on first setting is is our is cowpox, in for elsewhere. approval pathogens, well all An partners this with for greatly paperwork monkeypox. facilitate drug against the preparing of as in in approval human use Institut University includes up TPOXX smallpox and Central exported in that indication arthropods growing African broader would to the requests Africa monkeypox use as site, international with threat also use virus monkeypox necessary disease the the of cases additional All Republic. place, countries. this by to has provided clinical effort, of managed in the in Oxford TPOXX in trials and additional they’re their patients other

use Thermal oral in which afford include TPOXX We the development are patients for pathogens hopeful underway activities that revisit us opportunity strong acquisition and the will for with FDA to of of other orthopox safety animal to there data. indication for is data potentially TPOXX the and TPOXX. monkeypox monkeypox are the efficacy broadening

Based weighing than X XXX the day an modified to study of this to overall will Of population. First, the label in discussions we’ve on kilograms, XX% treat results FDA, completed suggest a will volunteers the which the post-marketing with XXX effectively after conduct the size PK in commitment the more a U.S. TPOXX be approximately of is in note, a to and milligrams population. outbreak, case patients. adjustment times these reduce stockpile of the

quarter progress. TPOXX clinical After during Last agreement post-exposure we reconstitution our fourth plus for larger the smallpox in for such, the design. discussions Current improved recruitment target, powder JYNNEOS to antiviral. If available of to data of as we trial and clinical ST-XXX are our iterative analogs will immunogenicity PK JYNNEOS terms use most will study from our importantly to And file patient are support clinical The will have FDA, regulatory data advance with plus in to and TPOXX and of completion to trial prophylaxis first been important respect to be pediatric predict adaptive commence to the on TPOXX will quarter developing aimed CRO continue partner use transitioned these programs, formulation. the protein upon conducting development of of approval. the With XXXX. studies, leading we have ST-XXX results stage and continue safety obtain second start for drug computer to PEP. activities, XXXX. should TPOXX formulations we approval TPOXX recruitment the patient of the with the the of data cocrystals half Defense X The of The that at our Second, Department modeling And with collaboration expected our begin to as XX-day advance TPOXX characteristics. anticipate trial immunogenicity in continues most we trials. be its efforts of XXXX. earlier

in of Additionally, a to and we’re months coordination provide tularaemia. coming resistance financial preparation hand will of you update, we to part conducting against as experimental broader development done developing actively plazomicin being for antimicrobial the work the for animal support plague plan This experiments RFP is an to as that our that reply collaboration. over With in a we launch with which to to Cipla update. Dan expect the I’ll part of

Daniel Luckshire

Dennis. Thanks,

and XX, September $XX.X revenue was respectively. X and $X.X X the XXXX, million, For approximately million ended SIGA’s months

the the quarter, military. million revenue oral third relates Canadian For to approximately of to of product $X.X TPOXX sales

X sales of adjustments which million have the and for XXXX, to excludes approximately months ended Canada loss, warrant, $XX approximately product the months oral ended $X.X income, million XX, months more For September sales or interest X Operating the September taxes relates fair XX, to the Canadian XXXX. ended military. was XX, September than product international and XXXX, revenue Agency approximately the X of X-fold. In to TPOXX million value comparison increased Health of Public the the $XX.X of

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

XX, XX, net diluted loss X for $X.X share At $X.XX X was per turn, cash X a the the and $X.XX ended September a share months the approximately balance the September In XXXX For ended was was approximately million. XXXX, September months loss company fully $XX for share, XX, million. respectively. and

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

As program of since approximately has Phil. XX, At of million share to turn XXXX, over XXXX. repurchase the shares the this call. a total financial company its cumulatively repurchased X.X concludes call of the inception approximately the the at common March the of I’ll of section stock point, in September $XX of million This

Phillip Gomez

Dan. Thanks,

contracts like support SIGA strong that are in the view made collectively. Q&A, been that Before I’d In when organic offers reiterate we initiatives existing turn that combination to an viewed by past. attractive growth complemented have our few generating that points results currently to potential hold of financial a of significant

is international generated I’d approximately First, like $X year, initiative value that XXXX, has In highlight generated this our Year-to-date ongoing million revenue. manner. sales to and first a revenue. creating sale initiative progressing in this of international of the $XX this initiative million growth

noted not that well developed, on is that to many lumpy front market shape. taking given as this international for the progress international we uneven, believe expected meaningful times is While and a market is before gradually be biodefense

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

sufficient who and earlier, courses those to be of a need million X.X TPOXX would believe we stated stockpile not all treat the care. of would smallpox outbreak As

to Third, as to the with be And, initiatives future we aforementioned government broaden Cipla to RFP would with avenue first and for we that growth expand customer expect an initiative. of U.S. products one the important of base fourth, U.S. is fact, portfolio a in And in collaborations diversified our contracts. be in such respond the and include could ongoing portfolio coordination efforts to the believe Defense Department on Cipla growth others. shot including this goal our to potentially the

through earnings, time organic for the these last cash, share when successful potential potential significant our diversify examine of we creation. contracts investments collectively leverage or to use cash and growth as continuing best that as business grow growth initiatives viewed acquisitions As provide our our mentioned well And have we continue earlier, platform. one existing generate buybacks value to will point, an initiatives, as including we opportunity and over believe

Q&A may our repurchase at announced authorized under $XX session. XX, we As million common SIGA the prepared stock concludes company which program, now board call, through XXXX. repurchase new to December the This company’s the remarks the the and last will begin up we our of

Operator

session. question-and-answer [Operator will Thank you. Our time, conduct Group. Instructions] Please At first with from proceed. we comes Jacobs this Maxim a question Edison

Maxim Jacobs

provide appreciated. transition a mean, Thanks My XX-year on too detailed figured, that detailed update. potential very be. was might color you contract get can probably contract. much wondering on for on It’s the question only I Hi, of just timing the I if any the is that. guys. to you what I can’t

Phillip Gomez

Yeah. very question. you Hi, much thank Max. It’s for Phil, and the

So in products it. very predict I FDA separate to a it over get usually once the But approval, part is government difficult historically, their the of say, on timeline in there to a contract U.S. government. a would multi-year transition is

to in ultimately, There of as we of make makes under different first the over pediatric hard for BARDA. lot structured, the learnings the is we’ll we my years national to procurement and But in resupply post the certainly, Preparedness over have COVID-XX. working that’s said time where into to formulation. supports that X sure the to an I over ongoing settle of and BARDA a sense a got period with R&D because out did. the And of Secretary remainder opportunity contract which how part going the going contract. develops the that’s So as we and Assistant the strategic the the fact discussions is the next be government organization to advanced BARDA smooth ongoing remarks, been for stockpile. BARDA, are transition have transition. well and development, work as of be Response. with that under our we stockpile, a with We But to currently IV it Historically, as

again for So thanks the question.

Maxim Jacobs

Wonderful. much. very Thank you That helpful. was so

Operator

proceed. investor. Our [Operator Instructions] private Please Green, from next question comes Teddy

Unidentified Analyst

the I Hruby Hello, was guys. you Dan. That Hi, see surprising. I Good until that actually to wasn’t a progress little think and expecting military Dr. approval. received the Canadian order. on Phil, the

that’s see. to good So

be for as U.S. stockpiling. the marketed It’s First existing only correct? question I sold have you, label for for a product only that to the in TPOXX, obviously, and Is

Phillip Gomez

where That is correct. That’s the description. label

Unidentified Analyst

Okay.

least the the sell European labels? or those with Union, application the For are the at outside Canada, to including of in in stockpile future, you for ability and

Phillip Gomez

the what that near end be to that ongoing So an Teddy. the conversation label final would comes of the process has, as

near So, necessary to regulators wide so feel patients. product certainly, patients to more lot there more in to the a but there as with could how broadly, be requirements the that lot say government we’ll sales. versus know, have to is Clearly, indication thinking Europe, monkeypox that I an the end, and But a want there wait do will we’d the are that we’re and conversations that be see stockpiling to the routinely healthcare. ability involvement monkeypox, in of happen that’d have get you have about

filings and is forward. something going is our a so we what And is what between government distinction private sale it the a regulatory progress, looking but development and as at much certainly sale is narrower, we’re certainly

Unidentified Analyst

Okay, also. into Hruby. been virulent Are clades, be know answered University. that have monkeypox clades trial clades, with monkeypox clades the over the this It’s Ebola, And than, And this that’s Africa question, the the up or I’m Republic I Africa? better good to observation the that monkeypox true in if African Africa the Africa. clades in Ebola by in you holds to curious for Central that hear. set Central clades appear Oxford in if with Dr. West the virulent the Central West more monkeypox Nigeria more in say, just And might be my say, then, than the carrying

Dennis Hruby

This is the Thanks for Dennis. question.

on be Africa effective are equally West Central both may we and clades that expect correct absolutely Africa Based to more Central sequence against TPOXX analysis, You’re clades. virulent. African

Unidentified Analyst

been then, great. Okay, ST-XXX, also, in to regards some come there issues. issues And Dr. identified? have you. had Thank to a And kind any solubility issues? Hruby, been those there were of up has And I design overcome read those

Dennis Hruby

that funding analogues optimization need them, up initiate external hope and come that. chemistry do issues We’ve soon we certainly to a to campaign, and think identified will address with to we we receive

Unidentified Analyst

you great. for Thank that. Okay,

this have notice of Phil, then courses industry capabilities, was the of Sought within in think excuse came notice we just obviously end September, is And see the asking obviously, and – of final I is, sole to out, then Department that source. is Sources the then, a out from the question notice Army notice October, purchase sole the U.S. TPOXX. of October, there joint just me, at to was which intent had capabilities original Okay. manager project to came of a And source of that Sought of Sources produce TPOXX. evolution the the to is Defense, kind intent of to middle actually I And medical

my produce guess, question I – are XXC capabilities are So, above and courses and what over TPOXX? asking beyond to the company’s see the is, they to contract of

Phillip Gomez

that, ask they be responding of a the needs pretty we’ll broadly ensure the can So to to to get DoD. to respond organizations think, capability from continue I common that’s

And so, only with we’ll the and to have government ability demonstrated we product safety profile certainly a feel needs it. TPOXX, that certainly great be have good deliver and as efficacy responding as the we profile, to not very a like we’ve but

So, have. any in work questions may with continuing we’ll them be responding they yeah, to and

Unidentified Analyst

curious, submit of and is of time, Or you of lot smallpox? getting treat – And respond in how then indication forward? it’s contracting it your before because Okay, follow-up then are that one in these days that. and take this row after that symptomatic to in purchase they process procurement kind it TPOXX, and I’m the I it, that have going ducks works goes of a with is, on their and what this label symptomatic XX anticipation and government, a a thing, to inactive. and to just just – curious, solely too understand to could I’m just have an be PEP thing on thoughts a this does – another the to

Phillip Gomez

One, X that they and surprising intent So, not closely that certainly that been think, guess, been for, to focus I going his ready we’ve and and I clinical the collaborating of go this certainly, a talk which I certainly able contracting, would they program, contract ability DoD received as funding, that have an And contract step have in substantial we’ve to And, point PEP a in the very highlight team vehicle when been a them. meaning are the used be people a details described, broadly, is agency is has a and getting being that’s an launching. and it not you there’s Dennis working government sell business having pride what levels. to conversation. TPOXX, work in for study on it contract, to something to no purchase their have it’s to and to to broaden important vehicles with first opening

posted for the we’ll for And PEP, TPOXX, having great government. very we’re clients for U.S. that’s other in is with and work about and the first excited step. with notice the the a source responding use best a the and that of strategy think they TPOXX, both on DoD we to conversation within this, So to sole what broad them responding on

set first by DoD. evolving the still been there but certainly, data anything as with formally it’s Teddy, say, step, I is and a great think you So, hasn’t

Unidentified Analyst

guys. much, it. very you appreciate Thank I great. Okay,

Phillip Gomez

you much. very Thank

Operator

Phil in call Thank There turn to further time. questions would Mr. the I you. are you closing like over to Thank Gomez comments. at back for no this queue.

Phillip Gomez

the the to of I’d everybody R&D of challenges I’d function there’s continue thank to ensuring a pandemic, work. in a to continues for for our programs our call lot chain like SIGA thank supply work the team and advance and like today. to joining and still whole also lot

all our as thank forward continues talking like we soon to So team look shareholder. to to and and our execute flawlessly, to all you I’d them

have very and thank good you much So day. a

Operator

teleconference. Thank you. does This conclude today’s

this lines your day. time. your thank at have great You And for and may a participation you disconnect

SIGA (SIGA) 7 Nov 212021 Q3 Earnings call transcript