Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, greetings and welcome to the SIGA Technologies Fourth Quarter and Full Year 2022 Earnings Conference Call. At this time, all participants' lines are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

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. any events update this or undertake statement any call. not reflect to changed does obligation publicly to forward-looking SIGA circumstances after

differ, X-K. XX-K Commission its Form including For cause limitation XXXX the filings factors and of report without year the please on XX-Q ended annual to XXst, Form with Exchange a on company's the see and subsequent and that Securities reports company's Form the for discussion results could December

you introduce to Gomez is now to It pleasure go Please Phil ahead. my CEO.

Phil Gomez

Thank Today you Luckshire, taking today's for the time I'm our join to call. Dan joined by CFO.

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

On of I'd call transition Strategic end of like or TPOXX to we the XXXX, year by expirations oral start would the XXXX. prior in in with our investor call be March recapping that for highlighted SNS. US XXXX year significant a Stockpile no performance National annual

I'm to revenue pleased our million And result or thanks prepared of this diversification the with to years has to outbreak. a in mpox respond the we year ended revenue been a for in to making. report This year, the diversification we base. global as approximately $XXX monkeypox were past

Our January to able deliver preparation by of mpox build included in inventory approval customers. to be TPOXX for the XXXX proactive EMA treatment of to of and our immediately

of sales to US more approximately sales US the XX oral million formulation and first of Overall, customers, included of TPOXX of Defense. the took than of Government, million XXXX TPOXX totaling Department the $XX revenues first $X intravenous sale international to the

it million Government. XXXX customer, approximately international cumulative sales one US had one and time XXXX only a only $XX of two-year company sold oral As to the buyer the the of TPOXX XXXX, reference within period to and of frame prior over international

oral the of in deliveries it Additionally, year in since Stockpile. that start first which National XXXX benefit company Strategic positive of without to cash be the flows had sales the the TPOXX the noted TPOXX of should substantial XXXX was any

diversification growing in We financial preparedness. overall world health of of security the different believe importance of the SIGA by trend recognition the emphasizes regions governments that of the

last TPOXX our broadened that for have being by we a generally in November, trends of building believe development long-term noted that call while. procurement investment activities in a is As combination SIGA business of and been driven

Specifically, by partly outbreak. mpox with international government of XXXX least XXXX in the connection at to we of sales the believe driven diversification TPOXX, was the initial sales responses

in launched, approximately internationally trials, well the of four trials cases mpox, as NGOs. seven placebo-controlled and and are TPOXX importance compassionately to randomized US agencies or have to and that study to XXXX, approximately to has TPOXX, there respect cases treat X,XXX the outbreak highlighted cases since than more global been in by of outbreak, which another scheduled many as the XX,XXX many have use mpox cases been TPOXX government which sponsored was given of mpox clinical With are of XX,XXX the be that for US the May used launched

randomized general November with currently levels of the trials of the the timing To be participants reiterate trials unknown. depend trial, call, to trials and enrollment mpox and these in the regard what the outbreak will timing November, enrollment. placebo-controlled on the of the ultimate and the likely of speed ultimate I the path of the said number the continues Hence in especially investor to

of submission composition means this mpox turn, for is the FDA an for and TPOXX label an also currently timing In unknown.

of believe continue since XXXX, mpox is While a forward. to presence the we continue third acknowledged global to it will global has have likely cases going decreased be that it should that, quarter significantly that

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

key continue forward, two we view. period believe Government. Looking this positive sales US company's our key a for driver by are We into XXXX the XXXX. will of financial the There and during will expect streak reasons performance for procurement be

while it be noted will Strategic we substantial the TPOXX National be during 'XX 'XX. in expirations TPOXX and Stockpile Stockpile Strategic the in First, National expirations XXXX, that estimate product there scheduled should there no were during

TPOXX when have we has XXXX as and it TPOXX, As oral XXXX and a that and options life, which for four manufactured issued XXXX shelf a products XXXX, the procurement reminder, BARDA Oral in million. in contract seven-year saw in $XXX.X BARDA option stockpiled XXC been options XXXX, procurement was valued approximately contained exercise in at as each expired.

the In in Government oral stockpile substance, deliveries with those of calendar years. TPOXX we US replenished

As will oral of such number of TPOXX the substantial manufactured believe XXXX XXXX. order in we being such Government TPOXX and a with US amount courses stockpiled scheduled XXXX, in expiration courses a XXXX XXXX, substantial of the in and

more second specific to the expect view a quarter. of get the likely order in We size

TPOXX National to contract under the procurement orders under we in believe within Government contract or XXXX exercise Strategic US the levels, unexpired would in make order least options at Stockpile. to new need procurement historical XXC a Additionally, the maintain

of US Response working second Preparedness that, substantial to under addition to the options we contract. a in in exercised will be sales revenue with the the SNS near the XXC and get reason source for Administration the company believe is or Strategic term Government BARDA ASPR, A the key and

supply out to manage and have options and We to benefit contract engage of better the smooth continued deliveries stakeholders budgets XX-year with on long-term annual a chain.

focused a been the for we've this by And of prophylaxis that requirements Government. part US TPOXX considered new on PEP also contract, conversation postexposure are the or ensuring use about as a of

an contrasts which has for expected and fully course government prior difference XX-day the XX-day with order PEP reminder, quick a is as indication. require stockpiling, protect treatment procurement X.X million This in targeted the which Americans, in regimen, in increase noted would a of to regimen substantial a As number course RFP.

from could the made clinical clinical substantial On of terms to of important that ultimate the pleased In months this an progress PEP to meet sizing immunogenicity track we role. year. front, completing play the believe I enrollment prior investor trial and from in trials are the TPOXX immunogenicity last as over the calls, on patient the performing the in stockpile XX expanded recently safety with program immunogenicity of the PEP study. of Geneos results target the this March am trial we that report stated the samples testing enrollment Currently

readout Scientific are immunogenicity the detailed Hruby, Going the data in with a will Officer next call within days. forward, call, connection XX Dr. to trial our targeting the Dennis next PEP on update we provide the more join program. Chief the investor At a

the highlight for regulatory would for submission to oral program make TPOXX. like that Label for for impressive TPOXX to the SIGA. a XXXX continue oral early in FDA PEP for PEP Expansion PEP Expansion a an The streak is indication Label an I'd for goal Since achieved complications Continental mpox, Europe smallpox. oral has XXXX, approvals the treatment vaccinia the of beginning of EMA and smallpox TPOXX broad from a MHRA in regulatory cowpox vaccination the against and United of company the Kingdom for for following the

intravenous for May regulatory approval from in we smallpox. the of treatment the FDA XXXX Additionally, formulation the TPOXX for achieved of

to Dan At this point, over I'd for call the the like update. financial to hand

Dan Luckshire

Thanks Phil.

the of revenue Department million XX remaining TPOXX million supportive which SIGA's to of $XX TPOXX sales, approximately a the the the sale development IV another to $X Defense of revenue to The December activities. to approximately months revenue million, TPOXX to million $X $XXX US related related oral US Government. is first For approximately revenue of of and $XX approximately approximately of XX, research international and million, revenue relates further ended mostly sales XXXX oral and relates was to of

represent to comments, to and TPOXX first and Defense TPOXX of base the from of sales expansion sale Phil's US first customers the XXXX TPOXX of oral meaningful of reiterate earlier more with a IV XXXX new To international Department Government. the a prior revenues base than XX to revenue US the narrow the

work resumption contract. Government under revenues the generating will customer on also expanded procuring from sales XXXX, the Government replenishment For while continue stockpile to for -- of the XXC to pursuing US of substantial the base, international we replenishment US and

contract and the we continue preparedness the with to through procurement IV in additional orders pursue connection Defense new the administration with the exercise a Department of XXXX contracts additional US Furthermore, of option will work coordinate TPOXX Stockpile on with the XXC deliveries strategic and/or the potential under of IV to National US contract Strategic to response. to and Government

results, income share warrant, approximately fully operating $X.XX. $XX financial for of XXXX excludes year, income million the the $XX pre-tax the to the adjustments income, was Net was and approximately and value million. other for taxes was fair to XXXX income diluted Returning per which

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

capital special cash year common to approximately of activities. was used million per of million repurchase and Approximately full $XX a June XXXX, XXXX, share shares million million paid was for $XX dividend approximately was the used approximately management the $XX for For company stock. $X.XX in that used X.X

calls the in the using This inventory drug Please concludes proactively addition work that, activities, mentioned management process has product in note well investor cash build to using company on prior capital been as cash final to update. as inventory. financial for as

call back this the to point, Phil. turn At I'll

Phil Gomez

Dan. Thanks,

existing that attractive Q&A, believe that offers significant XXXX a support when to highlight turn We financial and like points of is we and hold an viewed connection potential, ordered delivered, view when results, Before strong points streams collectively. product SIGA our combination that beyond. complemented organic in initiatives growth I'd to by generate with these revenue few

areas. highlights value in many of likely been broad of the like and to reiterate It the therapeutic and countries is receded TPOXX degree I'd used or across stockpiling long-term past customers mpox the in of has significant treatment the and while that, series the Canada, orthopoxviruses. a leading other TPOXX. in our with Europe, is to over has US, of months, TPOXX has importance outbreak usage XXXX The of the being understanding Asia been that nonetheless it of highlighted differentiated region, the only TPOXX the connection that range the Africa Pacific any First,

the value-creating outside customers. reiterate we a base a to that, solid ongoing like have who initiative of international international progressing is growth customers TPOXX, I'd sales manner. ordered have XX US, With in Second, the

this believe we gradually that variety factors, a lumpy a reminder, uneven and shape. continue of international taking As is a has to progress be to meaningful although, been expected quick front on market given

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

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

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

revenue a prospects. in company's Fifth, future of resulting expansion is our the diversification of thus revenue the of portfolio base customers enhancing

other could Sixth, markets open initiatives for and pursue up TPOXX. we and oncology strategic continue new collaborations support to that

As viewed I these we for when have significant potential a believe mentioned creation. initiatives value collectively earlier,

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

Operator

Please Ladies first Soo you. gentlemen, we be Edison conducting Instructions] Group. question-and-answer from question and a comes ahead. the [Operator line Romanoff this Thank Our at from will time session. of go

Soo Romanoff

questions. my is PEP Once terms Group. the steps on Romanoff This quarter. are pursuing you readout expansion? Edison the trial, stockpile in My from taking Soo immunogenicity for the for likely question get first is you data of next what Phil. from Thank Congratulations the

Phil Gomez

to talk to Thanks, Soo good you. and

on with the showing immunogenicity the have. that immunogenicity the a point scientific question for key trial really we So interfere open that we don't us is is

We've program. we've discussions our overall them for plans been PEP. So with government on TPOXX in the on the briefed

process get their determination helps we on information ultimately critical decision-making to as stockpile. a able getting data of the be size So on the that them with make to that

decision possible. Government. this time in Thanks. to predict But options have pushing So we can't and the our US is process. be that exactly to very the as several contract a their decision But government we have soon for as year is to data sure defer we'll made line on we hard coming given make the left out do

Soo Romanoff

great. That's Yes.

XXXX you customers? international second the from sales for to maybe one So Dan. repeat in come expect new is or customers Do

Dan Luckshire

Phil that times So mentioned we investor company maybe base this let start or I'll year. the the I'll think mentioned is in but I jump is, then as a as meaningfully has Phil few expanded

And build goal to so the from And has there's then more always than with and XX contract establish customers. relationships and these customers vehicles there. been

I'll And to customers look But to did the So those sort ordered it are that of we the Phil potential most customers initiative. some key I safe market that the the degree turn to of last that in big leaders out. international ongoing order markets. build XXXX. to year list some buyers it's comments. about definitely buyers, in think add then target when of the an think to is say amounts and And on of are you that say, big would some over will the I potential

Phil Gomez

side Yes. Dan Canada And is I that the initial order had as I'd a they started had think to an Canada echo military orthopoxviruses. about we from then of think small said. came again instructive. we those order civilian call you the what on broadly remember, of If

but preparedness So mpox I a well are only orthopoxvirus customers opportunity continue for those to key And to broadly. about build are as customers the looking certainly we're they to about think certainly new existing pursuing there as some us we not think outbreak, relationships. think as

a be question. the certainly for it Thanks will mixture. So

Soo Romanoff

If squeeze one in. question could I more

any studies this think the is Phil. in placebo-controlled for getting the chance data more in Dennis there I near term? Is monkeypox from thank and on you. And

Phil Gomez

Yes.

If are a increase last NIH do. And question their at to those sites what like FDA of we as to complex sites approval package be roll as the expand trajectory could a that the our question the we working One as data cases will in out. see would trials outside about look to mpox certainly outbreak. did partners with an easier enrollment it's the US. spring make So for international to tirelessly the

study have Africa. in ongoing the in We the DRC

We UK up study and working in geographies. others start to are the that additional have

that We also it ultimately CDC. have by evidence we be anticipate the real-world will published

an And shorter-term. to that is people that the I If studies. very low levels time combination we're a the all think so could is to some Thanks. both real-world seeing there certainly placebo-controlled were plans we'll a data of there watching at for come happens see interim in for good readouts some the Maybe case do what of the thing see health outbreak. to have probably with what are a in evidence happens it load. readout But and the but key have and spring what those interim we time that public continues

Soo Romanoff

you. Thank Great.

Operator

Thank Thank questions. now Ladies of you. are gentlemen, your participation. further concluded. and SIGA has no you there The conference for

may You disconnect lines. your now

SIGA (SIGA) 2 Mar 232022 Q4 Earnings call transcript