SIGA - Earnings call transcript Q1 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 statements 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 31, 2021 and the subsequent reports on Form 10-Q and Form 8-K

Phillip Gomez

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

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

US capability in the the in with million SIGA's highlight BARDA not performance the TPOXX of since our we XXXX. the XXXX under of followed need this We current to government On the results million attractive of XXXX This importance of results operating $XX call in the believe is strong of scheduled we results that have financial XXC XXXX last expiration. last to orders the The there secure noted does pre-tax highlight for on contract. immediate also year, income. $XX pre-tax Also financial and financial XXXX deliveries stockpiles replenish discussed operating expirations business. US government financial no call, income for

our following and in longer-term advance chain. BARDA with continue noted, to to contract further and options previously with deliveries options as work better out on exercise and to efforts smooth the work annual On such two one and budgets we to are XX-year As ASPR continue track, manage a tracks. we supply

such procurement there years. the other orders next wave government of for that the pursuing be On expect for position orders the track, expirations series for we year. we in the a initiatives significant US that oral as are scheduled a And stockpile no we're acknowledge of of coming XXXX company this catalyst that ongoing would TPOXX

initiatives. the discuss me Let

like would to IV I talk TPOXX. First, about

US the we IV the government of another toward FDA stockpile. Concurrent IV would decisions. NDA a with been for an have May future consideration date have for US believe of also and TPOXX has regulatory we that terms we mark government to process, in procurement TPOXX key working XX. a will it PDUFA Regulatory that noted, filing with of previously be delivery the approval milestone As

of for reminder, million IV pleased a As our $X order XXC base the first to million approximately contract. in IV also first am am we which with deliveries TPOXX in BARDA in of TPOXX the pleased delivered We that quarter. order. IV made note $X the note there CDC was patient highlighted MMWR in base of the IV the an I contract product under was TPOXX I publication monkeypox the US. use to was treated in a our by a that

sales. this initiative for to order The million Public second international On to PHAC has continue With to oral of front $XX approximately respect build of involves on we our Health I an discuss base. placed the would like Agency Canada, TPOXX. Canada,

this fill in order to expect XXXX. We

that consistent Additionally, the the Canadian order military be both Meridian approximate and coordinating XXXX Canadian a would in size to military. with previous to and expect of SIGA pursuit are we orders from

around and continue future discretion international their TPOXX. additional product anticipated in ship am I TPOXX. the discussions to customer. new of East is With plan to business million XXXX the but recurring Canada, this Asia of we year to Europe, the be pleased a Pacific this Pacific to $X.X Asia respect solely have This Beyond each procurement in year. development, region at approximately of report approximately We $X.X country from in Middle the order the a oral order to to order we for new have initial a from country million that region

will to our there discuss involves like with two. talk multiple US With The expanding I procurement third government. footprint are the initiative regard I to would initiative this elements. about

government BARDA. beyond with procurement pursuing contracts the are we US and ASPR First,

base on would believe of the have relatively procurement primary we been source Defense benefit. of we US as government of with we as financial the broadening TPOXX, be While to Department provide sales procurement well coordinating a expect front, to continue first ASPR On small contract. the contracts strategic with this US procurement

We procurement open are we expect the DoD other competition soon. published of only is than has the in their suitable following for connection procurement, to drug process, why justification In pleased with summary details TPOXX this PEP. finalize of TPOXX use highlighting

second study. expansion effort to element PEP The the the US involves government-centered

the can important would pandemic calls, to will results not of sizing those to Dennis? the PEP As has believe from that and care. noted will antiviral especially could clinical outbreak who From the and treat play in to perspective, ultimate current progress smallpox turn in the would active prophylactically. used TPOXX be the broadly of prior who the provide PEP our need a importance I the be that program. details timely over those in of PEP Hruby, including on highlighted Dr. the we stockpile, be access sufficient R&D now having that clinical the regulatory all update call program we and an Dennis nearly investor COVID-XX of role. the stockpile Substantial program would terms a believe drugs,

Dennis Hruby

Thank you.

mentioned, trials needed executing, our support two post-exposure Phil approval the we're working to clinical regulatory As for with DoD on prophylaxis. of colleagues TPOXX,

U.S. which expanded For screening will shortly. initiated clinical begin we've the around set study, have up safety dosing sites XX and the

two TPOXX recruiting the immunogenicity trial and JYNNEOS have we sites screening plus volunteers. For

the enrolled part enrollment. U.S. working the been We're study, has and eligibility to so to in other among side. to slow post-COVID effort volunteers expand broaden as hesitancy due the enrollment have to accelerate on in with DoD been first factors. is recruitment the the This the vaccine Although in criteria the

goal is XXXX. both for expected commence activities of study for the the results, we would active requesting quarter package PEP. TPOXX approval For assembly If third the regulatory the showed to phase complete by the volunteers a of the have all studies

will disease in to by targeted our pediatric NDA used is a in requests for swallow advanced our Clinical review to unable most this This We've those IV to patients advance FDA. XX to with for Likewise, submission will As TPOXX Phil less medication. pediatric and May. than information in under we be use is weight. discussed, responded with positioned, to addition believe be all virus valuable also active in the continue and countermeasures orthopox well the commence for fall. studies an oral kilograms reconstitution promising our in our powder patients formulation approval formulation,

As smallpox. mentioned through just previous think the we about for of treatment calls, a viruses, TPOXX in of investor the family being not orthopox lens

with As TPOXX. treating such, we monkeypox to work patients continue towards

safety our We're TPOXX extensive group a As increasing patients. animal is patients different to set trials cases to and a in currently facilities in working where for of Oxford country. clinical It with a have on a note, you mostly Republic that treated there health are We're collaborating Africa and Central up to U.K. and It's and difficult in African with a countries of was the successfully extremely cases exported humans. clinical different are study U.S. these rare. access and University this number second quadrators, we field cases also study larger including care on important approval used to numbers these in of other been received areas a African to effectively occur number testing the EMA reason for in of infections in know, much both based patients. the monkeypox, treat have

will the future. progress, to continue updates make As in provide we we

the Dan. we Europe TPOXX cases jurisdictions. are approvals. is Canada SIGA With three approvals various Finally, associated post-marketing and with received various to by there R&D diligently some in The the studies requested commitments requested to with turn the the initiate team information over working update, and I'll U.S., these that call the provide in

Dan Luckshire

Thanks Dennis.

the which months under three ended the the U.S. revenue SIGA's revenue Pre-tax of and of XXC related remainder of approximately excludes interest taxes $X operating income $XXX which $XX sales TPOXX of to XXst IV research was was fair relates $X.X approximately three warrant, BARDA months March was contract. to government is the activity. development to the for the was the balance XXst For and million, value XXXX, March approximately cash the million The first for months loss, to approximately million. fully company three At XXst $X.XX. Net ended XXXX, the and diluted XXXX was XXst $X.X March share loss million per million of loss March XXXX. ended approximately the adjustments

Phil. building are financial allocating first XXXX, that of we tool point, also of shares million. capital common allocating start its proactively of ingredients, into for repurchased the approximately pharmaceutical repurchased update. inventory, general in the stock, cash cumulatively back risk program March SIGA supply call cash I'll concludes quarter, note, Since $X.X $XX chain this million management as to risks. for turn March heightened the work-in-process shares environment repurchase This have XXXX. approximately of million a given as active one in addition initiatives, to the Please management of During SIGA approximately the the share of At we into XXst

Phillip Gomez

Thanks Dan.

the initiatives that be May tactical record As discussed per operational call, in XXXX. date dividend a payable and share, to earlier special have June on a a of $X.XX on we XXXX, announced will of cash based Xnd XXth complement this

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

XXXX contract wide is sheet range As wide part financial consideration. balance With that possibilities among a is expect considerations. procurement we place and of solid XXXX range a we this of period, to the dividend. Time million $XXX a it to remaining of BARDA an to exercised and and XXXX consider process a currently the of and our time performance, strong special cash in believe time we appropriate on options be XXXX declare

from going confidence and sizing will performance action of considerations of range shares. plan reflect optimism balance. the initiatives. and repurchase to will full to to the dividend reflects a and a of that The a believe, related comes reflects the implementation range business stock also a XXXX continue XXXX price, procurement financial timing timing this repurchases also growth-related that The of to orders, We potential note, future pursue company of of special forward. including of the allow On about continue cash we and amount

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

sales need initiative value-creating a antiviral international ongoing smallpox the continue to that We including countries, base. growth highlight to have to expand recognized is stockpile like to three US, manner. that in progressing now and the hard we I'd have a that work First, the

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

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

If earlier those to to the stated would size believe we TPOXX smallpox outbreak current calls, learned from certainly treat As and be who on that need would case. all care. the we've a appears of stockpile sufficient the not anything be COVID, of

long-term predictability. on a to diversified appropriate supply deliveries, the new TPOXX annual Third, which collaborations well success continue initiatives focuses for base. Defense other markets support we could requirements that transitioning will including we US chain and planning out adding Fourth, as our TPOXX. of portfolio Department customer SNS smoothing will growth our oncology to US and contract stockpile that is to financial critical the open contract And the pursue to strategies be focused for and on as fifth, at size our anticipated be

remarks earlier, now when collectively, This special and viewed a reinforces these will value we have concludes the we growth this potential for creation begin mentioned dividend and we message. significant of the prepared session. Q&A declaration As initiatives, our believe believe

Operator

you. Thank

the We comes Instructions] go ahead. Edison The Group. question-and-answer will from now Ken begin session. question first [Operator Mestemacher Please from

Ken Mestemacher

I results And you. Again several questions. had the team solid congratulations Thank on this quarter.

be it first you just the they're I that of to had to clarification the make trials and correctly. mentioned the for PEP XQ by going XXXX, registered correct? one that The sure that Is want talking is end volunteers heard about us I

Phillip Gomez

little PEP a trial provide you on timeline don't if more why comment that's helpful? the Dennis, Yes

Dennis Hruby

Yes.

the studies but calls part would of the fully have the which for and and by phase study be by patient both will the end study the completing of to quarter. done QA'd the like data be treatments to and QC'd Our after reports, the be with volunteers third active of third we the to current their timeline enrolled quarter

Ken Mestemacher

you. Thank Great.

you if say go do so And file well, that for the PEP trials PEP could with XXXX? believe two the FDA in you

Phillip Gomez

Dennis?

Dennis Hruby

That will bit the little up. how to it written depend a on data get long takes

data QC the it been surprised to XXXX. takes I've it reports. be scientist, long assemble our As to a certainly, starting then to goal get package FDA and But be QA final how in continually the would

Ken Mestemacher

the supplier. little be made DoD you a mentioned buying that? of points why TPOXX bit, they Switching the What think source the were Great. might key summary you single in and are some

Phillip Gomez

Ken. Yes, I approved is it's in TPOXX do that one treatment a great want only explicitly the US. And point for say to smallpox

So, their a thinking drafted for which been on they an FDA the points TPOXX a protocol why access the label PEP to two for that they the is through that PEP purposes looking I a already gone have study. think could expand saw until we've But PEP. indicated sole they're be approves doing as procurement expanded is published they've source used TPOXX and procurement critical we're with talking as about as this I

I think to adverse they PEP was before we really to and DoD appropriate document. FDA second that's profile, was for point what the exactly the that And be approval is the the important in event we then as the PEP. saw that product use government our have So, said they for in purchase certainly the ability consider product and said can we've highlighted only dose, TPOXX tolerability,

it And in those nice with see said we on so was to both And we in them of as work procurement. comments, points to them continue publish think, I that finalizing our those documents.

Ken Mestemacher

sales, on you. that then, Thank Great. see -- And exciting the again, to the congrats APAC expand. that's

many you other purchases the it? a see will potentially So of countries how new annually. would model purchase mentioned, maybe make you as that country Do its

Phillip Gomez

We're Yeah. most an some basis. whole depend type seeing of of do on decision annual variety certainly models, of which on a

order, intend no were So, What contract. they was an do see Canadian in a there have contract have government or in shelf for which to annual US just may rather every most about period moving hopefully government order that way as those orders, year single a your stockpile conversations a and a the over the you're on supply order since governments of an you to But they something predictability other time, as chain, the at not following initial simply think us are where every we're large annual new so that from do is appropriations countries there see purchase, we be year to and your build these issued of the for manufacturing it but options then want base we the question in then simply the life it the budget people an order year. finances. a for about but and becomes new there's in side XX-year to recognize a are their a for discretion, plan able to and contract being one we able exactly annual, that and thinking

but the we're where that's different think in markets. models, international the seeing we certainly So same headed. And we're intent

Ken Mestemacher

excellent results. congratulations questions you. on the That’s Again, I the thank have. all Great,

Operator

question Please ahead. The Investor. comes next Private go from Kyle Chung,

Unidentified Analyst

I Thank to a a taking threats. against to a radiological the or EU population in there sort Roughly ago, you for my protect defense strategic that have reports of some TPOXX smallpox were and month believe stockpile? biological would create stockpile either plan if Do you the that know press Hi. nuclear about included is question. chemical

Phillip Gomez

Thanks Kyle. question. for very Hi, much your

is in you landscape the Europe highlight So, evolving. as

products The they there at we've that that things, a the closely going of tracking provide is of centralized There benefits, intent imagine, some so that and can was colleagues eventually year, There in about in chemical, articulated as stockpiling et threat. now stockpile initial HERA NATO has active say, strategy at isn't product focus can European to EU, a important procurements I create develops think conversations Meridian be through fully Meridian. back they The one very drugs, yet. biological, that that entity EU So they're types influenza. intent that decisions. going that But remains a are very Europe. that a with But announced stockpiling cetera are can both kind you discussions country-by-country over nuclear available a those to level Europe colleagues yet called as figure been was of but actually our radiological the BARDA-like some European vaccines, about have what of to entity actually the with is having for Europe is these start their and is with and national and best they still stockpile. as NATO SIGA of set COVID, and out the are that pool very

Unidentified Analyst

you. Thank

Phillip Gomez

you. Thank

Operator

on would the There Phil over Instructions] I the for concludes session. remarks. phones. conference question-and-answer more are Gomez to like turn This back [Operator closing no any questions the to

Phillip Gomez

I'd to call. today's thank like So everybody joining for

a the $XXX million into if kind we focused to and the will we And over disciplined evaluate it. company we've ensuring use share capital. is approach on said remaining we've again, as demonstrated and that of might through good we've deploy discipline a certainly talked the return half good being of contract M&A of make that of we accretive. what I Board strong we continue years We'll the cash disciplined sheet. a continue that balance options investments we As cash dividends, be strong through to to options, about, past potential had we BARDA think couple sure look with go in demonstrated the that make as think is XXXX-XXXX as forms of efficient all essentially very assets XXC deploying very to approach I we on of buybacks, of second over But and at and

you to you call. to greatly so talking on today updates shareholders the additional providing you call appreciate and next much. and with we So forward Thank I the quarter's look our forward joining look to we

Operator

call. today's This conference concludes Thank you.

may lines. your day. pleasant You participating a for and Thank disconnect have you

Phillip Gomez	Chief Executive Officer
Dan Luckshire	Chief Financial Officer
Dennis Hruby	Executive Vice President & Chief Scientific Officer
Ken Mestemacher	Edison Group

SIGA (SIGA) 8 May 222022 Q1 Earnings call transcript