SIGA - Earnings call transcript Q1 2024

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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 uprate publicly any forward-looking statement to reflect events or change 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, 2023, and the subsequent reports on Form 10-Q and Form 8-K.

Diem Nguyen

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

on strong a our to delivered SIGA a quarter level. Overall, high team as continues execute

TPOXX both million, advance reported reflects XXXX. of certain $XX a our million placed over the quarter, the SIGA our strategy. revenues performance the of generated of steps the and of income operating U.S. oral international orders up the value comparable quarter connection this These In from and pretax by Our and the with team, we're product were $XX revenues the of strength government. TPOXX franchise taking to first delivery of in

this performance. throughout be current to for central remainder in the is We BARDA the the believe oral TPOXX under financial diligently to our contract. the lining is will year. expectation up order near are strong A working positive term of momentum that We we XXXX our receive reason another confidence year sustain another of

initiatives management. In choices, for positioning on exercising our long-term through results, generating strategic durable capital and operating are SIGA focused success key disciplined strong addition we to on executing financial

approvals our are partnerships regulatory and therapeutic capabilities TPOXX; strategic our of value: X global the TPOXX partnership of leveraging We doing new three, two, initiatives expand into continuing cultivating the through in to shareholder number complementary access with government; four, one, this to drive areas. advancing the formulation; to U.S. move to indications

and oral This move connect to it our effectively also promotion not enhances enables we the Medical of outside XXXX. effective ability of control to our for and us took seamlessly. with key Meridian the international place on X, progress made serve customers amended several Technologies quarter, This U.S., and the A fronts. TPOXX June but the development in agreement when our more marketing promotion TPOXX April we only

Additionally, wealth our marketing by industry presence, believe is a this leadership rising orthopox our We grow and spread. procurement new strengthen crucial brings of to appointing pharma a Vice which of governments strengthened includes international focused President to who and which approach and leaders. international viruses we experience, sales in private International mid Markets, more to

in In ] partner, new Japan, a in Consistent placed If early we anticipate will TPOXX with deployment that of drug mpox for to filed virus. Stockpile vaccinia our Biotechno the on expect receive the for due to TPOXX application that for standard outbreak. [ quarter. smallpox,mpox, the of Japan Pharma be third practices, approved, ready event update in announced treatment we and have complications filing on the cowpox April National an

indications approvals new and We the efforts particularly to programs. and to our fix our continue TPOXX in PEP also formulations mpox with advance

First, on PEP.

to requirements personnel. the we've days. humans treatment XX successfully data to As U.S. the use smallpox with expanded safety TPOXX to is benefit In strong under Defense confirmed for patients for stated authorized in FDA's trial the extended of the obtain believe access short, how Department its today This we last existing quarter, situations. consistent potential protocol with that safety profile. completed is deploy TPOXX in prophylactic TPOXX has This

an trial the mortality combination without the would likely in used in also event The FDA We completed immunogenicity we of committedly administrators requested a an TPOXX and smallpox vaccine outbreak, with. because TPOXX in patient morbidity treatment safety. population come TPOXX sacrificing to this to evaluate trial when with run reduce be

and working expect consultation from greater in the weeks. FDA NDA We're with continuing the path and submit with this the time, trial, it with analysis submission to on coming we're same early and next of collection to year. data work visibility the forward target At our on the in supplemental CDC the

gears Shifting Republic on the In the April, patients data. a large as trials these XXX increase and mpox enrolled had the our to patients of from enroll of of ongoing Congo patients, trials. collect in sponsor being last Africa, Democratic conducted continue XXX The NIAID to the call. PALM trial noted

NIAID the as last XXX April, noted of there also is In were trial, a patients in from the our patients, substantial increase PALM call. which XXX

reports cases concerning XXXX government cases, a like mpox DRC, and recently I'd about ever the increase declared proceeding, cases The Before DRC to deaths until an experiencing where than XXX of mpox its is more ago. recorded, in January over from largest XX,XXX acknowledge CDC the suspected in that particularly the epidemic. surge the with week

predominant and reduce death strain agencies causes XXXX, has illness global DRC, during strain known [ severe supporting as outbreak. the in ] compared investigators to the also Since more SIGA the health XXXX I DRC in Furthermore, the mpox been impacts the disease. and of the to CLAVE devastating

capsules use a it's trial placebo and clinical We for the XXX have TPOXX of DRC. in over matching randomized donated already courses

We situation continue actively assistance possible. provide to when to the monitor

to Beyond continue Africa, orthopoxviruses the world. perminate around

sponsors We best trials for mpox outcome with achieve to to possible trial closely and are possible analysis the their working to as complete mpox committed quickly patients. as

As vaccination a label [ the and been cowpox to against mpox, has U.K., following treat smallpox. reminder, complications known in tecovirimat broad ], TPOXX, and SIGA has smallpox, and Europe as approved a

approved U.S. been collaboration trials under market, contract next in to to to our with any to U.S. stockpiling. smallpox forward remaining the TPOXX U.S. ongoing the orders has as we TPOXX U.S. treatment and with supply SNS we the Pile, mpox for current Strategic the in TPOXX National work discussed oral the ready government for contracts and for close are of important fulfilling regard With look earlier. Canada, PEP to the In as

U.S. responsibility $X to over government reinforces spans decade with Our and partnership the our about security. totaling with and contracts collective health commitment a billion

shareholders health patients. our We value collaborate for provide data and achieve ability the outcome on government to security, and to with are superior best U.S. confident to them the public

and with a with future Our reflect value secure potentially aim is long-term today label. the expanded a contract to TPOXX in annual that

reminder, of Medicine Academies of by Sciences, As the agent recent Category Future to concluded and State is a remains smallpox can enhance a well report used that A related the Smallpox a Engineering and National this action according bioterrorism CDC, vaccines Medical issued that outbreak. to diagnostics, smallpox for and and needed therapeutics to as response to as diseases U.S. in Countermeasures titled be readiness improve an

health and care the COVID-XX health outbreak strengthening pandemic to for threats. the public The XXXX in highlighted opportunities mpox systems future response U.S.

profitable, as to a therapies is disciplined company vaccines approach are strategy, do by a robust and prepared intentional. or our combat naturally with accidental TPOXX and capital essential We our a proven to valuable resilient occurring, to believe and operational we whether are an Overall, outbreak, effective management, capabilities. a part franchise supported strong team

while with strategy health. we maintaining advancing believe our focus our Combined, executing on will enhance this public time. are We over shareholder urgency value

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

Daniel Luckshire

Diem. Thanks,

$X of of sales comparable including the period. U.S. in ended the for deliveries $XX the earlier was financial in $XX results ] comparable months U.S. related mix call, March XXXX. approximately customers a of to Product sales substantially of the and and first XX, million located of March oral of the delivered product quarter customers, time sales to X the TPOXX Europe. approximately $X XXXX, to TPOXX diverse million $X quarter oral Strategic XXXX international noted to to Department U.S. in As government, the X were in million those approximately Defense delivered XXXX delivery Approximately the million X ended was Stockpile [ were of comparison of to deliveries financial of million ] with for a million in X to $XX Product the in SIGA's results months XXXX, the customers. for National [ surpassed XX,

of in of versus income, the of per interest quarter a XXXX. XXXX. $XX approximately in turn, Net period $X.XX share first approximately XXXX versus comparable million XXXX. XXXX a first first income for was quarter pretax for of income the comparison, quarter was the approximately net $X of loss of is a first per diluted operating in first the operating million excludes Pretax which In was $X In share $X.XX fully in the fully million diluted $XX the of loss XXXX. quarter for there approximately million comparable quarter income taxes, of and loss

At maintain amounted to balance XX, to On strong no and paid million X, sheet $XXX XXXX, approximately shareholders. approximately of million of the which the payment dividend a $XX company debt. special SIGA continued per balance cash with March to an share, disclosed a April cash previously $X.XX

Diem our momentum. positive forward, earlier to diligently mentioned we continue by as in working are call, Looking the

current another financial As BARDA of XXXX performance under such, in we year the up receive oral another is that based to we be near term lining the strong on our TPOXX contract. expectation believe will

back concludes This this the point, financial to will update. the turn Diem. I At call

Diem Nguyen

that, to execute With where end the continued I'll delivered a at We on the levels. I SIGA partners remain focused benefit for team long-term high strong of Thanks, for positioning as SIGA success patients, our and began. shareholders. our Dan. quarter

call open would the like to to Operator? I Q&A. Now

Operator

Soo first your from from Instructions] And the [Operator Edison question comes Romanoff of line Group.

Soo Romanoff

everybody. before, but I And we we see on hoping. maybe of $XX in it -- that question to is like as kind of we million oral for had we've had we in, of come up like first and contract. challenges chunk spillover million worked of Great any be My it nice big lot that time. seems were expect TPOXX going lining quarter. assume? to into this a Or Do IV there manufacturing some to $XXX the was It's XXXX? Congratulations, out. seems some that the balance BARDA we and for kind a XXXX, believe I things TPOXX of got

Daniel Luckshire

Dan. question. Right. for the This is Thanks

question. there's X of of In parts I -- terms your guess

vendor of terms 'XX. In mention did you issues the in packaging

we of back that a to getting rhythm So working prior really -- XXXX. have we into in with vendor we the process packaging smoothing are had terms and that been out

vendor. have is relatively this of it was last long-standing As did a And We historically, towards background, hiccup end year. the smooth. a

smooth anticipate working for prepared So much as quarter. it as with to an we be possible really to have been we upcoming and be out them what

of other in probably the about delivered XXXX, comes just but whether the where XXXX. terms little specificity specificity about government a really considerations timing the Having and that, on we deliveries. comment on that XXXX in be packaging is will in and all the are not deliveries the terms order reason with premature it's vendor, versus also of So of talking and when in when to -- said wants vendor it's say the that

there So series of arable. a is

on as So more year, details the we in clarity little there. get we'll have the a further

anticipate as to up lining on we be and would like do our I highlight, based we to prepared strong our XXXX do a though, noted remarks, financially is that in order, an that we expectations. believe year

terms in but so it do substantial, And specificity, to we think we'll to you. have back of be will get

Soo Romanoff

also now? me Could know Okay. how contract, is the helpful. on some contracts for That's be Meridian And like you amended terms really for I fee understand might international fee the that then figure little works of different. help the revised I is a there that The I Meridian mean XX% sales. think previously, internationally around new distribution. the

Diem Nguyen

Soo, let that take me question.

So to first, ability our me serve amendment let and more highlighting enhances customers is the that strategically by and our start connect seamlessly. important and effectively that it

international to were the reduce are European to international I those and to Regarding Kingdom. Australia, that there say, will -- and the percentage Switzerland second, United Japan, percentage the fee. If will sales the scope high for be of fee summarize, the economic for I able area, reduce XXXX, in were June subject amendment, single-digit the of sales the be would X, that sales fee effective terms the to subject fee a we a economic first,

a role than those about not Japan confident United and to other in in sales ability. play and will ability have economic a We're direct Australia, sales our quite and international International area, Kingdom of Switzerland our fee. European the the enthusiastic more

Operator

Terry. Your next from question Brian of comes line the Adams from Carter

Brian Adams

I want of to Again, you questions. reiterate just quick couple for guys. A a quarter great

the and fourth you when correct? upcoming the the Just fulfillment tranche a -- of agreement. speak I'm of Is that original contract, assuming that's clarification, BARDA final this the for of

Daniel Luckshire

within is that oral contract. X option in be each, for there current $XXX for the the would -- there's correct final options fourth million and you're this Yes, TPOXX, and

Brian Adams

Okay.

for how of track part or QX some also then time be of first So it on And And that do would based would the passed. that late potentially of is or been happening discussion TPOXX in the the have filled 'XX upon cadence time orders you B the in early 'XX to a department? of the secondary in Part question, the are for run talks now? be defense a a begs

Diem Nguyen

Thanks, Brian.

Although we another National haven't some for for issuing the administration plans preparing and Stockpile, we this time yet year. its response received RFP notice of strategic are U.S. preparedness from for the about

is as of annual the aim with as based today PEP. expanded value to provided contract the well the long-term Our TPOXX include future on will that label, secure which purchases a reflect potentially mpox as well as

Brian Adams

then Okay. secondary just And a question.

been in feel as of With -- the the you how on your has so, a on how color the FDA -- words this going is STOMP months or of getting this? trial, of XX-odd and frustrated from results? any kind has good which it some put long somewhat the not to do or And results mouth, taken as for comment far long

Diem Nguyen

by has trial the STOMP NIAID over and patients April. as XXX is the it noted, of enrolled From perspective, sponsored as

the from last recruitment we STOMP patients which trial, what from month. was increase call. roughly to the month substantial enrolling for XX date a about per XXXX been has is highest there noted April So our currently

So the the we're with pace that we're high frustrated fact at not all recruitment. given seeing

variables relates will guidance we recruitment it complete. cautioned lot target there's would enrollment, the be XXXX. of impact a that that FDA As in until will timing fully current enrolled And on is to be study

our However, to file can. FDA partners working closely soon as we as with with are we

Operator

this at questions further no are Please There time. proceed.

Diem Nguyen

I'd to again thank like quarter time call evening. for speaking look SIGA. your and operator. interest today's call. to forward good the of for join our to everyone us Thanks, making on a ongoing in Have We in to second really rest you

Operator

today's you call. for Thank participating. Thank concludes This you.

disconnect. all may You

SIGA (SIGA) 7 May 242024 Q1 Earnings call transcript