SIGA - Earnings call transcript Q3 2024

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Operator

Good afternoon, ladies and gentlemen, and welcome to the SIGA Technologies Third Quarter 2024 Earnings Call. [Operator Instructions] This call is being recorded on Thursday, November 7, 2024.

I would now like to turn the conference over to Diem Nguyen, Chief Executive Officer. Please go ahead.

Diem Nguyen

Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the third quarter of 2024. Dan opportunity Chief on to by we Officer, our joined this appreciate provide am Luckshire, Financial our and company. I an update questions. update, the we'll happy answer After be your to

million outpacing I'm our revenue of year. third pleased period strong SIGA sustain new year-to-date momentum. to revenues performance, comparable strong continues that last well orders to with position quarter, procurement secured us in in share the orders the business These is its which $XXX to extend

note in sales our by our of request to product from to IV response far of include like year include year-to-date in new to mix the which Ministry Strategic Internationally, so deliveries would of first customers, diverse this revenue I oral Additionally, National that represents the U.S. of TPOXX Health oral sales one Africa a to Stockpile. led sales sources, Morocco. a deliveries in TPOXX and

end significant demonstrating the were of quarter, strong of revenues in and outstanding fourth At outstanding third for TPOXX. to demand substantial continued orders us XXXX, into of positions balance XXXX procurement the recognize the This the quarter million. $XXX orders

XXC which from end includes Please $XXX.X announced order the order under and continued the September contract of we July, the note U.S. balance most in began million shipping government the that outstanding this of towards October. into

strength resilience. orders the past over and built several sales outstanding our We the year-to-date underscore company's as believe financial well as months

revenue opportunities and on time. be drive earnings to continues performance our we multiple focus long-term base to Our as have and expand SIGA's strategic over

health the represents well our long-term We Strategic company's supply to TPOXX. contract new ongoing Response, National the we earnings to result enhance and well a the public the process, of as our Preparedness of preparedness. ASPR, part our to believe first we which potential a government productive we a us a opportunity securing and Strategic conversations continuing wide expect known forward, the for as new for nation's advance positions do as our significant Looking Stockpile, for step with take in of to as or officials SNS, range momentum prepare TPOXX to Administration contract believe in

As is prepared Research U.S. HHS, Department BARDA, crucial Development to the and Authority, this Center or Biomedical houses and Human initiative. ASPR the of Services, a for support within team and believe dedicated We the the well is reminder, Advanced public health or our SNS.

And to based the health U.S. on robust conversations, commitment public government's and these to treat the preparedness smallpox. in therapies antiviral of are maintaining we confident enduring supply

believe and preparedness the we at alone of both an complexity pandemic SIGA, effective requires neither outbreak. vaccines can that address Importantly, antivirals fully as the

defense an immunity, or important available preventing timely Together, and treating of real measures they treatments are offer preventive pandemic, effective a disease time not both a be by meanwhile, critical vaccines role While these line for and in tools available. may infections to a immediately and managing the ensuring reducing and illness. severity Antivirals, of comprehensive everyone. approach play building spread provide

comprehensive anticipate spanning X We long-term a years. XX towards agreement new working to

executed contract valued million. last in our at reference, of XXXX frame a As was $XXX

over to remain anticipated necessary the be the determined. place timing exact to changes many the the of in Given government, weeks federal steps take the coming

by political both issue, with administrations parties. Please across and considerations. that our a and health keep with security in is parties has from transcends experience This mind bipartisan elections both strong reinforced alignment been

Obama awarded Trump. contracts our were In last President administrations, under fact, President specifically X different and

through government. expect protecting XXXX, the In public further initial which under targeting SNS partnership such our new Such would we contract with of shared we're in the continued a contract. U.S. issuance would summary, a health include order of contract goal

University that human smallpox pleased license gears, and to broad our fully portfolio potential the the including treat the exclusive monoclonal preclinical an Shifting announced have of Vanderbilt to mpox. I'm orthopoxviruses, we've recently that range antibodies to a share of from

and the for to in TPOXX with portfolio long-term pipeline, our complements to the offset offers growth Further, our potential opens door it partners expands development collaboration of new in development government of monoclonals opportunities This franchise investments. this additional space. therapies

U.S. is these development contract via development of I currently expertise organization a through monoclonals The Phase Department the and third-party manufacturing. Defense funding proven biologics manufacturing with of in

meet we on these and, pursue data their the Assuming these input, with with monoclonals to of explore development are and government patients public positive health. plan to future stakeholders of the studies, needs the collaborations

Our growth an strategy progress. over to portfolio next create new to the over forward term. the for the existing of leverage requiring company's opportunities license years use efforts will cash this step develop marks capabilities long our important strive The significant resources to several efficiently our without in to

TPOXX is smallpox, and gearing continue program the up post-exposure to perform complete we its half to of collaborate began to the the CDC in to work the CDC for samples with reanalysis consultation the or targeted Regarding in complete analysis The XXXX. collected study's the immunogenicity prophylaxis PEP, objective. recently FDA to first the with of support

the FDA the are such, submission for As planning third PEP quarter in we of indication of an XXXX.

the and Infectious As or we XXX the from Institute shared of preliminary announced PALM analysis a Diseases, trial. NIAID, on results from Allergy National August top XX, line

significant was Democratic placebo, meet in design. the treated to with trial were of not for due days the the endpoint time this primary tecovirimat resolution humanitarian results While Republic not the the of of XX who surprising considerations in Congo, lesion study statistically to for study improvement did within patients mpox its a versus

are data believe the these and explore We early; those encouraged the disease. those are mpox an second, in we in by patient treatment other severe with trials TPOXX groups: as warranted populations. first, of benefits treated to additional tecovirimat's showing patient potential potential possibly and benefit Nonetheless, X patients important

patients, additional enrolling including currently being benefit world by Platinum-Canada the and STOMP, of help Several potential deeper around a UNITY, mpox EPOXI. inform understanding mpox currently the trials expected tecovirimat studies conducted trial are are and Four to sponsors of patients. to are

enrolling U.S. our of and the from the reported in The largest It's patients XXX South call. and of progressing primarily last of by up America. enrolled patients XXX with these on October, about NIAID is STOMP, well first is sponsored as week

would has TPOXX safety by volunteers including in supported a demonstrated safety models, nonhuman clinical patients. is and Phase by III and toxicology tolerated numerous I preclinical This animal primates, patients. strong data observations healthy mpox-infected studies well that and profile disease is in with clinical highlight

of than more been use patients treatment patients than efficacy as Additionally, administered for X,XXX antiviral in the lesions reduction have mpox TPOXX TPOXX lethal more to an for primates to as the participated X,XXX preferred mpox viral trials clinical demonstrated have assess treat has and for TPOXX of PEP in and with nonhuman and of load mpox effectiveness body antiviral virus. disease. amounts treatment infected Furthermore, survival mpox compassionate and

regulatory survival and lesions of in improve on smallpox. infected this expansive or the Additionally, data label, TPOXX TPOXX why a been for mpox. has the believe Based nonhuman totality highlights U.S. of and smallpox including EU the approval received has collection with we the shown diverse regulatory U.K. sources approval broad in for and reduced primates Canada the and orthopox scientific to smallpox evidence, and in

year. smallpox, regulators final standard regulatory decision virus. drug with in application actively Biotechno for to mpox, complications time Japan, next the vaccinia treat by our line, cowpox and Based early the Pharma In Japan are to the new and due regarding expect on partner a review discussions pending engaged TPOXX we we

SIGA. this time is an dynamic summary, exciting In for and

resilient and We are strong, profitable.

capital we delivering us future. prudent for and make strategy believe well solid Our is the management results positioned and

produce believe a Additionally, our will long-term to expertise franchise preparedness which time. smallpox we team meets TPOXX results, for our shareholder and over and critical sustainable drive need value the has growth

review the detail. With more that, I'll to financial Dan turn results to it over in

Daniel Luckshire

Sam. Thanks,

As period to revenue XX, noted is $X ended the continue was in million. X XXXX. Of for Product million quarter. the sales for this earlier X ended to months months comparable product XXXX, product XX, amount, call, third outpace for the sales in the September related SIGA's XXXX, the $XX September

in $XXX.X which the The was is $X third U.S. announced the TPOXX $X connection the oral XXC international the million and international oral first sales. Stockpile, Africa. the delivery Strategic delivery National delivery under represents contract, million The there to sale with sales order includes of million SNS, to SNS million TPOXX first to $X the In or in an amount July. quarter, the

to countries the U.S. ended including X With international of XXC comes government sales million of under $X XX, respect and IV of TPOXX Defense. from contract, sales for TPOXX million XX mix, oral $XX million U.S. the to of and the to million XXXX, $XX TPOXX amount Department a of $XX sales diverse to the September million the months product oral oral $XX revenues TPOXX sales

to revenues, research In also development and had has revenue. product-related company addition the

and revenues $X ended X For the XXXX, September $X months XX, research were respectively. million, million X and development and

the for income, which was and September interest X XXXX. ended income million excludes XX, Pretax months $X.X taxes, operating

X million. months In income For of XX, September X a operating respectively. pretax September for XX, million, $X operating $XX comparison, is XXXX, million there ended and the months and pretax ended $X the X was loss

X Net income for XXXX, $X was XX, September ended months million. the

XX, million. was XX, ended months income ended diluted X income the X diluted share was turn, income $XX for September the per In ended For XXXX, share months months $X.XX. the fully XX, September fully per for X net $X.XX. September was And

the maintain cash no balance cash At while a September company would strong shareholders. to like balance debt. of company returning and sheet XX, substantial a a maintained XXXX, I $XX to strong that million note continued the with also balance sheet, has to

a amounted reminder, to a XX, paid per quick a payment to As $XX which on SIGA cash $X.XX dividend April million share, of shareholders.

XXXX, of revenues balance our Diem we Looking million as in substantial call, $XXX positioned mentioned for outstanding the in forward, into XX. light September quarter of are in earlier order the fourth as of and well

up update. revenue year believe performance. product we concludes lining such, This strong the another As to financial of be is XXXX

At this Diem. turn call point, the will back I to

Diem Nguyen

for we Dan. open With that, call the would you, questions. to like Thank

Operator

first Prakash from [Operator question Instructions] at Group. Your comes Edison Jyoti

Jyoti Prakash

to X I around X questions. have

this? in started we the when deliveries the seem see ask any more delivered? the great to oral them being be latest that of have happening orders under for to can is related BARDA particular be Defense me the delivered Department comparison to When which of protracted order let we the question from chain-related So reasons TPOXX? supply oral order see are QX. can TPOXX. the IV Secondly, for for to there What constraints? IV Are TPOXX expect one to TPOXX, the other. My after deliveries in It's

Diem Nguyen

and, the I you the your question. IV. activity very, different orals it's oral stockpile order very So well activity, government predominant much formulation first the TPOXX IV. first context little connection between or whether Jyoti, U.S. you delivery thank the the with giving formulations, cadence of the the X of is its TPOXX in timing and start by Oral a is as so between as will for

as vendors well much The for materials. some process manufacturing more IV TPOXX different oral for with raw as process different the than use the is complex of

Given these with manufacturing TPOXX differences, IV requiring oral. times IV on are oral longer lead different schedules, and than

customers like Lastly, IV when on -- take whether to customers product take delivery. or it's are to orals, dependent would deliveries, like the whether would partially

As continue orals mentioned, contract timing XXXX tranche into and XXXX. Dan in started the from the the last of has will

Jyoti Prakash

the under contract. And on question the on That's Okay. just deliveries of Department Defense helpful. the

Diem Nguyen

I think I...

Daniel Luckshire

The timing share.

Diem Nguyen

Yes. continue said have into I this XXXX. started will deliveries the and that And year already

Jyoti Prakash

And Okay. second great foray you It's make Africa. efforts. question the to internationalization into is your commercial your related see to

Just the understand, of with seeing amendment amendment what or in your you Meridian, how challenges of opportunities are markets? -- -- traction want agreement your to since international kind

Diem Nguyen

thank So you.

marketing could gentle bring Meridian agreement by June few for in broad a in-house, administrative supportive the amended Meridian. all a sales provided the reminder and we activities international so audience, X, for effective the we that As except

building given been has with Since needs the current the relationships we meet of customers We're centered all as our spending as considerable customers. global expanding agreement, greater have to change of international potential business. time This amending around the the and strengthening control our around globe. us well our

sales Ministry the dialogue we the help the immediate start. and it horizon. opportunities to our in-house off with ongoing With believe to Morocco, we Bringing efforts Health will customers, depth of to of recent effort Africa long-term of over a has and international and great effort our our pursue the sale is the request expect enhanced of definitely

at experienced in any point challenges this transition. We have not this

Jyoti Prakash

more moving to develop clinical this details you've monotherapy in-licensed And or combination it's therapy And expect how a see to TPOXX? preclinical And plan the this Perfect. do a program. can great Can deal we new program on, a economics? as you you studies? us some enter to on when that with provide

Diem Nguyen

the extremely We're asking. strengthen portfolio And our orthopox of for you in-license in Thank monoclonal this Sure. space. opportunity recent ability excited about antibody we're Vanderbilt. the our from to be excited about pipeline the to expand and

a treat develop and We've and have look therapeutic antibodies, a as to we a promise with prophylactic them the spectrum believe, consideration. inclusive a and TPOXX. a to in as or from stand-alone These is smallpox we use broad could preclinical in of of as models potential well would demonstrated orthopoxviruses, potentially combination which mpox, treatment

well capabilities in suited best our clinical of we're the manner. believe partnerships a the Given in U.S. potential we as these therapies development in as to agencies, government cost-effective maximize

with third In Phase fact, the expertise the DoD funded manufacturing development monoclonal has through party I. through recently a antibody

As the work through development premature about will posted. we keep we clinical timing. talk process, It's to you

Jyoti Prakash

Excellent. And final patients these Can media being a that's recent TPOXX. I to reports SIGA? you have and question. mpox your if provide have There perspective concern on one been resistant some reports on for

Diem Nguyen

think I to an considerations us to think opportunity weigh Thank of in on data. important based to of totality resistance. for relates reports you on about it's some these it as always giving

first has shown extended to time the resistance animals with for start with that by evidence date in TPOXX will I frame. saying no treated collected preclinical an

Additionally, a than resistance number the population. X% CDC of reports in drug at patient in low, TPOXX. document it patients developing less remains small Overall, only receiving

resistance of patients number advanced immunocompromised recommended limited This of treatment observed beyond received HIV extended in courses the with have a those who primarily been duration. has or

report recent the I Weekly Report. think October the Morbidity CDC Mortality to you're referring is and

mpox. has finding to protocols. reported noted is in TPOXX warrant investigation sample with patients. future small does further important was and patients a guide Resistance of This potentially mild a treatment few This to

to important better reports. these documentation not to However, understand history I was that it's collected treatment the think note

treatment reports detection additionally, of as tecovirimat's about making the a number difficult mpox And resistance. profiles tested, related to omit important patient well drug it reach as of total treatment or these data timing, specimens to efficacy overall conclusion in

COVID-XX It's mpox note compared really the to important of or is smallpox less to influenza. to that likely or occur resistance

it RNA easily influenza. levels viruses low observed This and DNA than to less of resistance tecovirimat. viruses, example, just mpox to like are viruses may For I smallpox which the that mutate attribute and COVID mentioned, with date the

no to like to not there is would smallpox, demonstrated to I tecovirimat remind that date. identified have that everyone and we resistance

Operator

call I no we It questions. appears turn will closing over comments. have back for further the

Diem Nguyen

Have ongoing in for the interest company. good a so you again our to rest to forward and our dialing call. Thank to call in quarter much speaking of We evening. SIGA's you your for on look fourth

Operator

lines. and thank your we We gentlemen, and please you Ladies concludes today. this conference for ask that you for your disconnect participating,

SIGA (SIGA) 7 Nov 242024 Q3 Earnings call transcript