SIGA - Earnings call transcript Q2 2020

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Operator

Greetings and welcome to the SIGA Technologies’ Second Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, today’s conference is being recorded.

Before we begin today’s call and turn it over to 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.

the these the could Securities year company’s Commission X-K. without of differ, results and ended discussion on Form including, see report XX-Q and please filings limitation, reports December a XX, factors for its cause that to Exchange Form XXXX For XX-K annual subsequent the on company’s with Form the and Mr. to I’d this like turn the over time, to At floor to begin today’s Gomez Phil conference. go ahead, sir. Please

Phil Gomez

I’m to Today, by update recent time pleased second financial significant to Military, Canadian of procurement update XXXX year-to-date join our the goals in with XXXX of Thank on and Dan on deliveries and made and you and for CFO, the for call. contracts Luckshire, the and remainder and taking On providing the to BARDA our expectations today’s call, year. have quarter provide the the joined results, we are this to our Dan TPOXX we’ve the this BARDA progress will opportunity to Canadian related an Military. be an

our will regulatory I on an anticipated update. updates provide and filings for overall business Additionally, XXXX

Before I would on to the I in to hand over update of an continuing the the context pandemic. Dan, SIGA COVID-XX provide like call

pandemic in daily life, to As economy. evident nation’s the continues and our our global health impact

infectious manufacture economy has the can and in are to to some with under respect of SIGA, impactful preparedness. those of the in hard continually this us all and material control. globe timely deliver evidenced recent to importance outbreak any pandemic we fortunately an the around this by gratitude for working the not been continue make I’d The be and help and challenges in U.S. occurs has to we adversely and impacted dramatically the by like my Canadian to At the our reminded illustrated the and with to by express this their who bring the pandemic. in all deliveries have tirelessly are basis. a thoughts work responding pandemic how help it TPOXX develop employees Our tools BARDA once disease. to in disease so many Military, been happen. private that on here the devastating outbreak as And our impacted sector, have and public for

Later pandemic or not have that timeline as For do overall any this an by due commitments the approvals. such anticipate FDA the will delays a or update. for that or must turn such provide impact and trial clinical financial any adjustments for on we on programs potential We near-term COVID-XX welfare expect do partners. point, TPOXX regulatory trials, requirements within the made oral Prophylaxis I I material participants, call, over Dan the to regarding a update delays At progress these business. the upon of our call their required to and be would our programs will sites PEP have potential approval based potentially, the post-marketing clinical and protect program, the to Post-Exposure of safety

Dan Luckshire

Phil. Thanks,

connection of the XXXX, the $XX respectively. and three XX, connection was is million $XX approximately interest the For in costs oral ended income value approximately income, which balance Stockpile is Canadian million and of Net with the to approximately, revenue oral fair Operating $X.XX June and $X or revenue $XX million SNS, was respectively. the the term June to June diluted approximately and Military. XXXX, TPOXX per XXXX, to three the delivery of million ended Strategic respectively. $XX interest respectively. the in related TPOXX million share company million amounts million approximately in and EPS of loans for the cash XX, taxes, National the $XX six these XXX,XXX Included share per months income, $XX SIGA’s delivery courses months with At months revenue of $XX retirement, XX, and expense, approximately adjustments XX, turn, three for and million. for million warrant was June and the In was six $X.XX fully and ended to six $XX approximately the excludes

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

U.S. the expect an approximately our SIGA to momentum expects continue U.S., to the activity courses and forward, Strategic respect the National XXX,XXX of we In procurement with to TPOXX Stockpile. Looking to within deliver internationally. oral

delivered recently their those deliveries revenues occur courses such generate courses are to of of expected approximately XXX,XXX of may and XXXX. million. In TPOXX These addition by deliveries April in $XX XXXX to in entirety oral

to BARDA a to In few the BARDA. up we the million in minutes. procurement-related discuss this $XXX exercise options XXC international of for addition contract expectations, remaining With to on market, our overall these has progress front by regard future will

the procurement XX,XXX we with Military point the a have value which delivery general market. for $XX TPOXX, contract courses the for our the contract, oral options up Canadian starting Military note, a Canadian a of the has As this expanding believe of international in approximately million. is Under to

the Meridian are Medical call anticipating the call. We section At after Canada, in This approval targeting this TPOXX Inc, under we for of which these concludes are the Phil. XXXX. of contract point, options under financial Technologies, to procurement I’ll to over oral the occur regulatory turn with

Phil Gomez

Dan. you, Thank

of like meaningful from the quarter a the quarter the that financial started milestone BARDA view. was the TPOXX point SNS important as XXC contract. heard I’d second from represented to you’ve an important of Dan, second under to delivering highlight amounts As we

plan. of significant shares to second the the the TPOXX half to of second to our worth recent the and deliver part SIGA of we product approval EMA the deliveries repurchase the made the happy to in of years regulatory of to late report TPOXX purchase deliveries the quarter extends to are importance a as upcoming in gears, international for be the to Shifting note our stock our front. filed to of news I’m to July; pleased we I’m million good active that is believe occur starting in including step XXXX accelerating value that broader demonstration we’ve note product customers expect important is a indication Please future the TPOXX. shareholders, $XX of Furthermore, first ability of EU applied for point this TPOXX. of in We for for oral deliveries an label of time in SIGA the positioning this come. sales

year, cowpox, FDA label vaccinia smallpox, of expansion treatment discussions of to pursue to the includes plan with this the application same future. indications and complications. We late file monkeypox Health and similar Canada the in with set Our

are the on noted, next submissions supportive are within back at international good believe international of and/or are international for business our we advance months. current these the and of very being international conversations, we for relevant. pursued additional call a and regulatory based comments contracts to front, with and On prospects development. countries looking the status still six to the range previously update conversations broad this As last on TPOXX Stepping picture, orders materialize broader oral business continue

focus it but the which in good believe broadly, COVID-XX the pandemic short-term, we noted As slowed TPOXX. some pandemic is on preparedness increase for has will conversations them,

TPOXX it remarks, programs. of outbreak. event of to respect PEP I’d important closing for the and to it oral a continues PEP, the With people on to addresses in like IV an likely Before development in I briefly a uses of be majority that make touch the program smallpox

available this year or is in program FDA or years. those U.S. We an program would to to in the either hit we sick coming the oral to NDA file program, XXXX. late update. on be milestones the capsule. updates will IV provide business important an IV this with the ensure early unable to as regard the with expect TPOXX This we This swallow concludes too to

For the highlight that momentum my has to to with approximately this oral the quarter. number second courses least TPOXX at twice closing courses the remarks, of near-term. significant And I’d SIGA of in be delivered financial expected XXX,XXX of in coming delivery like

of million part total includes of our capabilities PEP under orthopoxviruses, TPOXX for expanding the In quarter, execute XXC we bright, and believe of note the additional U.S. Technologies, $XX cover in leveraging Additionally, sales is million for June new to delivery collaborations BARDA for we which finally, of to remarks international concludes products. our expansions formulations pursuit now other seeking begin with that repurchases repurchase contract, Medical Meridian of and as to oral and repurchased million PEP XX. we and our TPOXX approximately courses our second stockpile expanding and which ongoing on label authorization; will the of continue the Q&A prepared for This to to we year-to-date our of and session. stock approval supporting include oncology TPOXX amounts summary, $XX share like SIGA the common I’d strategy, continued $XX future as will

Operator

you. ahead. Paul Instructions] is go coming Saunders Hedge first Please Our [Operator Thank question from Capital. of

Paul Saunders

stockpile numbers until of and quickly, the times congrats for U.S. that case generally say like really we I PEP expansion kind Thanks stockpile sort how pandemic, from U.S. progress virus and the a label we’ve the more life agreement the the all COVID spread would the commentary months kind if I quarter and it guys. in And for provide color cases stockpile probably you’ve real are that see, around the My of around of you say increase of that before of expansion. maybe, And mentioned. just you or just million presumably, that COVID-XX given really an number’s amount. purposes, a question Hey, can obviously here just can four is made. expansion, X and accelerating almost got I people about PEP have study call with really, a to regard good any XX on

XX for smallpox. from about or as third talking as a virus you’re a So, people contagious that’s half million anywhere

that I for rationale side really wondering million government to kind So, provide protection courses much I’m smallpox TPOXX, outbreak. just sufficient and X.X is guess, potential of the the of

Phil Gomez

Hey, Paul.

question. your thanks much for So, so

So, of in a that. couple response things to

disclosed the we government concept would I especially, our increase. is not That encouraging X.X the short but that U.S. I should through would would is articulated use disease ensuring impactful be of the that and very vaccinate to are those flexibility having that infectious it be X.X government. response on is believe things as agree million not an a of and rapid health, the done in the U.S. That with with publicly could PEP, economy and allows was to the that late that RFPs and exactly is, determinations, shown you the the there’s threat would by around the million course, stockpile for of PEP would though is be sufficient only that be inside method know, you stockpile the think has from process be answer too calls potential of important important. in treatments part current not future epidemic also couple an how given expansion.

recognition prepared been part, second believe are can we that that so is always the there’s and yet, purchase. that been has how is spent not have the U.S. nothing space I to to face and are end going the in would the date fully has budgeting as this this that’s certainly The encouraging that much getting a to not day and with they lens signs, government threats is and say as we spending us the that processes use that government, the there at a the through of commensurate sufficiently we encouraging but prepared being that finalized

procured around and finally, soon previously with the COVID. on short-term. say great that that, on We a that government we I we regulatory accelerate do those working they’re it’s they we the the progress though, bandwidth And in seen a had funding vaccines, so conversations had just is question. leadership inside very clock, around and bottom-line is we’ve So, on in on that appreciate would can. for to was conversations I as to There’s starting just could the started I in XXXX have focused within encouraging with your have XXXX. having we as I smallpox. be that? said optimistic ready as stand and I do wish, we leadership the the therapeutics, question, have TPOXX delivering front. have not in wouldn’t government diagnostics the assessments U.S. approval approval XXXX and though that no ultimate wait reiterate it FDA certainly we could with The to

product previous the So can clearly, deliver we that. to

So, appreciate Paul. question, the

Paul Saunders

that and Thanks the great. That’s congrats on Phil. again, quarter. Yes. for good all commentary Thanks, of

Phil Gomez

Thanks, Paul.

Operator

you. Thank

is go question James. next coming Horton Our of from Joaquin Raymond ahead. Please

Joaquin Horton

on with that Will Savas effect on what’s the board. firm? Good quarter, guys. the Paul resigned have from had going any

Phil Gomez

Joaquin? question. the you and Hey, Good to talk I to appreciate

new Ed background, a We has, in We at a member, a firm have he Executive the been the actually filed & name think has MacAndrews a an and X-K, his has Senior as see and that have is Forbes Ed Taibi. is long board brought time you’ll X-K. at do expertise. great

board. there. pleased got We’ve a great of So, we’re with the very expertise set

Paul the on although Savas standing we right to skills board a our a strategy. great the we have believe, and so And execute certainly long member was person, on

team So, don’t we B. in anticipate the

Joaquin Horton

And then of questions a stock in you the couple able end were of buy any – on buyback, quarter? other to quick the since stock the

Phil Gomez

have stock over So, comment don’t that repurchase do Dan hand to overall repurchasing. Dan, other on on we program? I’ll but share the you typically active any comments

Dan Luckshire

Hello, Yes. Joaquin.

plan we the we to is disclose the we activity. disclose for do Qs, our continually what and what So, did in did quarter

a comment now, So for right a don’t activity we on July. recent have

Joaquin Horton

thing on tax the Okay. on taxes, as And a long loss then as the you’re – have carry one forward. on phone, we the

I we that look So, it right? for like provision where taxes, a see but will made it. of Is paying doesn’t any be we

Dan Luckshire

have asset. We do a deferred Correct. tax

And statement, are sheet. income really you on the see – deferred the tax of it the provision tax asset that’s down in and balance bring so while the you correct

Joaquin Horton

So, how or? is is our there second any comments molecule on doing

Phil Gomez

it’s great question. Yes. a Joaquin,

NIH. preclinical. We the continue collaborate is It to with

to early, But that now, it’s of molecule? finding get a were advance out. we lead as the So a readouts phase do right on it on in certainly those optimization provide in goes go/no-go, it updates. we’ll continues teams and and of points, where have the can we preclinical get we next. as focused where We it’s kind advance.

provide points. as certainly those we’ll to decision updates So, we come that,

Joaquin Horton

to quarter, soon. you guys. talk Great. Great We’ll

Phil Gomez

Appreciate so much. Thanks it, Joaquin.

Operator

Thank you.

Our Please coming next Teddy question a go Private ahead. is from Investor. Green,

Teddy Green

that million eight stockpile numbers. of good were the to they to XX, – SNS about passed XXXX an government said I’m active. see on questions very share those incorporates budget the that functioning expire. to effectively provisions, earlier. XX, fiscal you happy want to noticed the the couple the And and what that. happy to also Hi, regards of the X.X house, year guarantee seems I at the guys. seems also and resolution to existing a see as the BARDA Congratulations don’t stockpile maintaining Very that see have me in I is quarter. Love question very buyback A courses, and the to, SNS that stockpiling content which stockpile

these I from courses SNS? So, looking the what would like to there know nuanced and that? how literally, BARDA are expiring a more of of the contract version is, Are is a that at original they or

Phil Gomez

it’s I So it. appreciate Teddy, great question. a

there. of I couple sure and make talk about a had answer comments You want I your question. then to

the the answer had at I’ll maybe, – the question So, end you first.

courses. really So, X.X them so about, and talk million work conversations their when RFP, We requirements, on have, have government their the they they think to through it. want and and with in and the of ongoing to option what that. only to don’t of statements allowed around RFPs in talks them RFP, exercise procurement their say, where, stated the they’ve the maintain it I documents year they but they and this our specifics continue suffice their stated exactly it. closely intents

come. look we forward so the to in years happen to seeing that And

is not They which SNS the who like including to felt one, you SNS. they up, get have that really Response, Secretary probably funding of and fully everything included the And SNS I variety brought have Preparedness we in over increase the fully is point said some enough in substantially funded the at there’s SNS they’ve the have not do what’s again Bob and conversations. what think important what in but The years stockpile, we for be would they a you budget, And to COVID have has wished interviews Assistant a recognition that had that other potential retrospect. be funding. that showed Greg greater is The been short funded that have have out really it that statements think point product. repeatedly Burel, There’s that there to a that. fund past people, should in the additional fully we the a need had we sure really make not is said don’t didn’t had we we and that said at was and Kadlec to wanted caught in look policymakers public house that want broader Director, only who’s similar least did to

our stakeholders, policy than that be and there of should would Hill conversations COVID to through we’re everything’s which the to that on an organizations in is ever administration much we devastating by know of work needed, and of Capitol So, encouraged importance going be and we the the to that unfortunately. outbreak those have ensuring continue including more we educate smallpox, know

have we really Thank to you. So, well-prepared. be

Teddy Green

for shouldn’t produce is that medical the of good Okay, I just the API And you take other other SIGA counter great. and can two to questions your company believe quick fully contract to minimum needs Project SNS and long. have for do provides a yet? other very fundamental I I Has hope lead them, BioShield and answer the backdrop companies Yes, time then from amount options? what that the transitioned budget measures.

Phil Gomez

needed they to would that for to and advantageous of and in options people like maybe were ASPR variety I’ll able had frankly with question Teddy, the if industry the conversations, be it they the this if I but So answer, do both government, We’ve time, depends. when Hill second lead a be don’t on quite Capitol advance on and first, answer the administration well it delivered. of with

after able an well advance. in budgets place companies orders reality government, made, and in And could to with production is they do their delivery. can the to is the caught start order be so organizations within advance The plan up haven’t and deliver what

saw, have soon as to wait So, in do you but thereafter consultation they that every until we option because they’re the government, get We with had delivered exercise. they funding year. and obviously, an we actually their hamstrung,

So, cycle a we longer have I could time. wish

a have they’re place ability raw supply chain, forward materials, ingredient. the whether to in active We materials,

managing being what is U.S. and believe so timeline our And proactive we ability in the to a responsive are to manufacture government.

you said be if to to want went that we here year, and we answer but in internationally. an a responsive that there’s says, from it’s we the know get-go, a over So, customers previously U.S.

chain, proactively we’re supply make pharmaceutical be can to as possible to managing our So, that like sure most customers. companies responsive we as

Teddy Green

on that. you Got

And other question… Okay. maybe,

Phil Gomez

Yes.

visible On the the BARDA not that to outside a it’s SNS, so world that’s contract.

for So, not countermeasures, comes do anticipate would seen several that would and as and that’s there. be issued do longer transition They we We other an disclosed. time contract with long time funding we’ve We’ve recently seen contract for the a negotiations XX-year medical run period. internally in SNS to periods.

of type certainly the we discussions on. We’ve would to. that’s contract started like move So to

be the that into funding BARDA would next side. SNS from line that out so goes your the to And away our phase point

So, stay tuned on that development.

Teddy Green

Okay, great. the the congrats Thank guys. again, you and for on answers quarter,

Operator

you. Thank

is of Esopus Sole Andrew Our from go Please ahead. next question coming Creek.

Andrew Sole

think and any you address COVID-XX in you on of have company. whether any vaccinia Thank of vaccinia virus have utilizing the development administering excellent you where could published this COVID. Hi, sort on going the question, you to virus be potential TPOXX play for There for my of Do the the taking in and a the of reports, that’s work Colorado Phil, thoughts role thank there some hi, around possibly light Dan. to risks been behalf seem vaccine. research researchers of your

Phil Gomez

of the one So not seen. referring you’re I’m thanks, to I’ve most Andrew. sure what entirely

many replicate. they developed City using would Dennis in much Ankara, was replication so called ago. there developed a that is used better smallpox vaccinia, the by to It vaccine virus Hope’s passage, been – the was think I Germans publication, that’s than Jynneos specifically was the what’s the vaccinia years which vaccine” modified incompetent. That’s that “safer are it of ability loses as as explain I,

used therapy, researchers have have specific So, associated and replication as company unfortunately, a certainly do and up. risks you you have look live believe be competent have the adverse yes, don’t vaccinia, mentioned, considering been events you that’s would know, potentially with one Colorado we not rescue I one higher for But there’s it the the then if relevance a ones, I however, events for prophylactic we’ll historically, the adverse but development. don’t vaccine probability know to

Andrew Sole

what for the State are from all thanks a of I over coming Okay. that and over there. great I you the whole very the But Thank Yes. and University. it shoot article. much quarter out can doing you and really team was was saw wonderful work you Colorado

Phil Gomez

so Thanks Appreciate it. much, Andrew.

Operator

Our Jet coming of next Matthew question ahead. Please from is Mark Capital. go

Matthew Mark

couple had I of questions a on guys. the side. Hi, international

I you did did next hear international the six within expect you First, the orders Phil, you months? say right?

Phil Gomez

Yes.

contracts next six We expect to the have months. and/or additional are progressing. within orders conversations our We believe

And on so that front. make continued we progress to hope

Matthew Mark

to very hear. very, That’s good

think So, regulatory do for not? or I’m going you fingers product to approvals, that. orders crossed the on those Are require

Phil Gomez

where countries with wait a saw Europe they smaller until regulatory EMA it’s our priority, application then deliveries potential conversations would. get other as We regulatory approval, approval. countries that said countries A we’ve gotten and that feedback. orders a until willing highest been mix, after procurement getting and to European a a said, also we and but as have did apparently with we’ve see of would after. to some before on want interested they few that have larger are We had have deliveries is that there’s focused we in the So, because approval do want countries upfront not Canada, they

a USFDA, great someone, it risk be is up low for in but have it’d their procedures. to So, think it’s package bag. mixed We a we the internal

Matthew Mark

and for Best much. very the Thanks luck it. work. thanks Got of

Phil Gomez

Matt. Thanks,

Operator

Thank you.

ahead. coming R. Investment Management. Please is Weil of from Ralph go question next Our Weil

Ralph Weil

what government do direct do on or work a something, just workings also. Okay, different which a quarter. or from they aware very Can are nice competitor and elaborate buyers’ is they I’m smallpox the merchant somewhat the you vaccine SIGA with the does? solutions of

Phil Gomez

appreciate from you. Well, thank Ralph. you, you question I to to and pleasure talk the

countermeasures response So, we multiple, that the the what important mitigate medical are to in to call outbreak. smallpox, are there

And so eradicate to smallpox. a which pile solutions vaccine ACAMXXXX, historically was makes emerging called used

the not however, a if you few we’ve protection. get vaccinated; about, you do provides has period. before infection get a vaccine days XX-day If incubation as after good within talked or it smallpox quite asymptomatic

asymptomatic. so you be And can

You might have fever a you after or the on you been of start XX% lesion, and chance got have not the after you have exposed vaccine to you to about vaccine when gotten may mortality. XX days and go have

at work. So TPOXX that will only stage,

We’re therapeutics the only FDA-approved smallpox. for

to very a in because it’s because time, so against routinely And immunized smallpox. we’re important everyone therapeutic, have not get a not will vaccine

the ours so And safety so pleased efficacy has in a U.S. therapeutic that’s we’re much on so a great the focused why the has animal models. in and good government profile,

so complimentary impacts direct devastating competitors. not of And we’re smallpox We in the certainly mitigate are outbreak. the helping

for question. you the thank So,

Operator

interest SIGA end the to would today’s question-and-answer us to thank for in brings We session. your like that gentlemen, Technologies. of you and Ladies

may disconnect webcast the now day. a log wonderful off You and have your lines or

SIGA (SIGA) 9 Aug 202020 Q2 Earnings call transcript