SIGA - Earnings call transcript Q2 2024

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

Operator

Welcome to 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 statement to reflect events or changed circumstances after this call.

For 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 its subsequent reports on Form 10-Q and Form 8-K. With that I will turn the call over to Diem Nguyen, Chief Executive Officer of SIGA. Diem?

Diem Nguyen

Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the second 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. I year. that update, pleased outpaced generate revenues the we'll comparable happy that answer After period the last be product revenue to has SIGA your report in continued to to am were and $XX million, Product revenues X and million X months ended $XX for the June XX, XXXX, respectively. period $X million and million, in This XXXX. product the revenues of surpassed respectively, $X for reflective are results SIGA's staying strong These of power.

Our been past special capital performance. several years, cash dividend activity over management the by long-term including reflects made strong substantial and the has possible

Our focus first of XXXX inherent nature the quarter-over-quarter the on fluctuations. positive supports We an X to months important financial long-term long-term the is due believe trend. SIGA's for and critical of business the performance results

a the to to U.S. international reflects TPOXX as TPOXX sales SNS, U.S. of IV Strategic diverse customers Defense mix oral the Stockpile, and SNS. XX or well Department of deliveries Our as the National deliveries

Looking our product important revenue year said to strong ahead, another quarter, Consistent performance. we base diversification what last with be of continued maximum long-term be expect for of will XXXX anticipate revenue. a we we

We robust will were the before delivery supporting of product X again It's approximately begin a that this portion stockpile XX ongoing preclinical be a reminder, demonstrates has foresee issue a our toxicology our that help of III Phase patients U.S. enrolled to belief to utilizing that delivery of and of to BARDA placebo ensure meaningful trials for a delivered the achieved revenues consistently procurement award within with in to for to threat. XXC efficacy mpox, deliveries Over the of smallpox plan security contract provided and TPOXX. year-end, It upon been XXXX clinical matching healthy an order the the work government product observations. has this substantial timing on to clinical Two commitment continues illustrates option bipartisan at currently cost. U.S. no next expectation maintaining this a over be $XXX and also based volunteers will year. will safety health government's antiviral data, profile data garnered the smallpox the the its anticipate its mpox As treatment as have SIGA assess that people as its of view past our of clinical American safety X,XXX weeks TPOXX days. We strong well exercises highest revenues the in the by years. trial sponsors government be TPOXX the and ago, under U.S. oral the of million support. TPOXX

a event will anticipate we result, treatment an in of be it an a As outbreak. antiviral preferred

now contract the attention government. securing Our U.S. is set firmly with on the next procurement

at any Our issued for to which of Preparedness Administration and with team time. by a request prepare RFP, as the of a Response officials broad for can or continues be government engaged proposal, be we Strategic actively range

of give we next this that a us While are wait for number there RFP, confidence. factors

This preparedness this and the government's earlier in countermeasures, federal government, increase budget for another includes the First, substantial the including the commitment to U.S. Congress ongoing budget year which the SNS. for outcome approved response. funding underscores

biothreats. Republic highlights the against need DRC, be world's therapies third, timely of for the or including to most X clade of the the one the the a procurement outbreak longstanding provide we and have government effective current includes dangerous the ready. like with Second, the This public Democratic countermeasure nations partnership a TPOXX. And response U.S. critical heightened of continued pandemic risk Congo, mpox to in health environment,

the by X only reminder, A our threat a immunity waning population. is is one of herd As smallpox considered CDC diseases and category among a

to fact, In contract, government confident value long-dated are countermeasures, that this was we with with contract, under And and years. contracts to surpass in delivered exercised. therapy and procure Project the as now well BARDA. All should most value between contract the government the collaboration medical SNS molecular officials among as SNS which options of aggregate X first is BioShield likely conversations the small a our receptive on developed new the XX aggregate been have our most to other of novel the in TPOXX was all, current based under

of SIGA. an current of is $XXX BARDA XXC signed value time has procurement frame the a reference, As for exciting a This million. contract in XXXX

security As I health bipartisan issue to support. garner continues earlier, that the an and said of is Americans

So while we are of our keeping next goals. this receipt we RFP, wait on focus -- our our for longer-term the

We customers U.S. summary, our government our once the the balance sheet financial the In advance financial and with our shortly. have provide ready the business with strength on to position process. Dan is RFP no further outside current debt. details to will robust remaining while U.S. collaborate with potential initiates it

pay to flow have allows remains cash we and April. cash us This Our special dividend prudent recently a management. cash in strong, exercised

Moving ready we starting Association announced an activities then, an areas. global for our on, team Nations. to productive April, drug future. of will highly If deployment and over next driving and strong foundational in has region began to we Pharma, in the is This Meridian growth with our review the smallpox, we've international oral Japan In Japan, Since of the partner, will new treatment are also a for early with an made amendment complications outbreak. SIGA for virus. Based vaccinia cowpox TPOXX Biotechno Technologies, for we the June expect we of Asian our standard regulatory sell have customers, agreement In new member which timeline outside progress event with conversations X. in promotional collaboration that states and due on for stockpile, to application, mpox, year. to several the other approved, TPOXX the a we under strengthened agreement in to continue the efforts regulators these upon TPOXX the populated decision lead the national Medical TPOXX promotion we to key confident agreement the final a U.S. the for step anticipate key in application by drug Southeast replace June, time. In relationships announced

continue formulations. We such in approvals expansion and indications to pursue of in TPOXX mpox new the as PEP

First, on PEP.

Jynneos. smallpox As to immunogenic evaluate of been I completed believe against much most focused stated that TPOXX a benefit Currently, has before, with the when administered a prophylaxis. has post-exposure TPOXX our trial safety we of work -- and in potential Jynneos TPOXX in together

requested to the Jynneos of because use likely event to The by FDA in test of an designed no As will outbreak. of and the was there TPOXX be this a was trial ensure or combination impact reminder, patient this safety vaccine drug-vaccine to together trial immunogenicity. an

is from of trial objectives. As a data safety reminder, the supportive the the

with same Regarding with it and objective. to working work the in months. immunogenicity, XX we time, collected out FDA analysis continuing support CDC an the next our the At are to immunogenicity complete within submitting targeting we supplemental samples submission are the the consultation to of NDA

corresponding line investigators growth Africa. to particularly for The to XXX with XXX in July, completed the capsules courses courses to XXX as to PALMXXX Recently, and last another Turning the in mpox in trial top TPOXX DRC, STOMP threat cases data in support weeks. of has trial, continues patients continue working We're trial our enrollment. donated the XXX placebo of access rise. reported The patient the to in we enrolled its broader release and progress. now agencies, data where remains of XXXX, NIAID call. Mpox ongoing To trial up clinical health and PALMXXX. randomized global access DRC during make from trial sponsors analysis. ensure coming seen donated continue significant considerable support from a also NIAID anticipate the We programs the over has we

future summary, approximately have for XX,XXX afforded situation prudent in X to company significant to Additionally, the government pay to providing patients. In mpox mpox our XXXX when U.S. actively, Number possible special assistance response outcomes is best compassionate to capital of by the dividends. monitor well-positioned the cash that program, us and has the the which supported management, to profitable continue has strong, we U.S. one, for the achieve outbreak. and TPOXX a Through well-crafted we CDC's possible is courses the strategy opportunity approach yielding we the Two, have a pillars. following results. distributed

to public these natural executing a accidental And review TPOXX operational is or we capabilities have resilient We our a pillars detail. outbreak. to our I'll who the Combined, turn with improve health. With requirement financial the the team effectiveness. are over ensure would established by urgency valuable time in and franchise it proven over critical results to strategy intentional that have U.S. of with Dan event prepared believe enhance more shareholder that, a we four, in fulfills the value on country government and

Daniel Luckshire

Thanks, Diem.

$XX As call, period revenues million the noted of IV $X year. were surpasses XX, and approximately million $X product sales ended and million XXXX, respectively, government. through $XX $XX related TPOXX revenues respectively, last earlier June primarily million, the the X million, product and for the in of to X U.S. revenues were SIGA's which for comparable to months the Product quarter

of TPOXX oral the the ended to months U.S. $XX including sales oral diverse IV oral XXC U.S. sales sales to the and XX, of reflected $XX Defense revenues the mentioned to XXXX, X Department XX TPOXX sales $X TPOXX the $XX million previously the international approximately June approximately under For government to approximately million of million approximately product mix, U.S. million of TPOXX countries, government. contract,

income revenues, June for $X was and and ended X development to for and the ended $X Pre-tax XXXX, respectively. XX, interest XX, company which million X had $X income, taxes, research approximately the million months excludes revenues operating addition product June In the approximately X of million XXXX. and months

June income months months million, for comparison, income pre-tax approximately and X $X million. XX, approximately the $X ended a X For for loss X was approximately of million. the was $XX pre-tax June the ended was million months months operating XX, operating there XXXX, respectively. Net XX, and $X X June ended In XXXX,

balance net months amounted special XX, strong approximately the $XX continued of per the approximately June $X.XX per sheet turn, $XX a And cash million June to per On ended was months the April XXXX, income income $X.XX maintain with XX, per the previously was share. June In XX, company $X.XX. dividend share, ended months payment balance debt. For diluted which SIGA X for approximately paid $XXX was X shareholders. an XXXX, cash and for ended XX, June income fully to a no of to fully disclosed million the share diluted share At million. X XX,

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

concludes This we financial such, the call point, As performance. believe the lining of Diem. be to another product up strong is to turn will back XXXX update. At year this revenue I

Diem Nguyen

Thanks, so government, our enhancing Dan. XXXX management the and growth our continued SIGA goals, from is optimal generated focused Leveraging believe strategic contract TPOXX U.S. new and advancing remain far a achievements this for innovation. including we on We the franchise. momentum positive capital our securing and with poised year,

deliver are our partners shareholders We value and patients, to will confident this time. the over

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

Soo Romanoff

Hello?

Diem Nguyen

Yes.

Daniel Luckshire

You're there?

Soo Romanoff

despite quarter. exercise Sorry, strong have of more mostly to XXXX you're some the color. another It going the a would TPOXX little Any portion timeline with be I come to had million these just BARDA are and deliver on it a multi-part meaningful $XXX you've helpful. sounds was hear across. technical like garner like color remaining on bottlenecks. sounds delivered manufacturing a question, part -- Congratulations more difficulties to It here. in nice oral I the the

on government the TPOXX? could sense remaining provide be The be, is, a July you we're will negotiations? believe yet to last I second recurring part the the $XX TPOXX could U.S. IV XX an I you provide some update of exercise when IV of arrangement. million was at would part kind delivered. And looking believe BARDA order the

Diem Nguyen

me, If I'm your to try X in you can going questions parts. hear to tackle

say produce for and exercise the remaining supply in government's the are government. sense here option relates is our this preparation the recent anticipate team on our customer, been do current that oral working of for BARDA contract. question And partners TPOXX to U.S. exercise option we've schedule I when coordinating under with with that And U.S. our we of would deliver the delivery. proactively we what to our first the makes and BARDA The

start year. meaningful to ability We a confident and the portion XX days, our are this next in to expect deliver shipping be to of delivered with within this

this cannot specific We time. at U.S. timing are government determine more collaborating with to optimal and the therefore, be

about we discussed asked TPOXX the question, the relates IV we your quarter then and TPOXX it the in you bit coordinate IV of today, was with you U.S. As we timeline the Once option. the option order. XXXX a million XXXX. I second to BARDA an final last the this chain will sales producing negotiations. background, that question finish government today of U.S. our second on for just $XX order. in the you Based $XX to give to the will was and the XXXX that had And on XXXX order, relates we the government on exercise that update supply know had, the do guess on million anticipate Soo, delivering what little

to increased From the discussions conversations, broad have prepared there we As we these bipartisan of ensure in clear helping with our outbreak the been mentioned And having start a the for security during health DRC, globally process. geopolitical government remarks, is are prepared is a and officials. range support RFP of in when ready given the of ASPR the we the to mpox American risk that people. respond

well the aim is open in higher As reflects do the with of today XXXX that's the a our a to long-term than value this government as to the up provided as TPOXX one years values contract. secure contract, mentioned, We to and a XX future. regular and with is U.S. aggregate contract purchases, believe potentially long-term more contract

Soo Romanoff

would ASEAN more If a on any more of bit, nice you're -- Agreement to I the one for the lot economics We kind if it's can would fee helpful. color a order don't oral touched little know ask also, I size, for there's mind. timelines clarity -- mean, TPOXX. The on I working with this too. see recent of the with And be Meridian. interest. be but the good question, Any then you on this kind structure Country new

Diem Nguyen

terms highlight economics. I'll agreement, in can and, the talk the ASEAN of about Sure, Dan, Meridian you

with in international markets. First, I want agreement, to agreement TPOXX this was our we advances that really which to highlight more signed incredibly This strategy are to access even further pleased expand June. to

region. groundwork Asia important region highly the for preparedness for in is to footprint additional future. and SIGA. a just establish activity populated a It strategic in contract region an the Asia growing also a the represents for orthopoxvirus step This sets

we We represent have customer As as financial the step a this over release, over to is our $X.X in member from did $X a the new terms we in ASEAN people the ASEAN to receive region. population important collaboration and noted the June million not together XXX of believe we order with first disclosed of states larger million a GDP trillion, date.

we have like would Meridian about you collaboration. Dan, the we're as quite with amendment? talk emphasized, this optimistic However, to

Daniel Luckshire

Yes, certainly.

to marketing it frame. original ownership time -- us we with it in early the the really allowed And earlier disclosed that, relationships. with June amendment So did was the take what international over of and

a ensure very off was of With the period time. hand goal the next the to for amendment, very, smooth

ensure Australia and regions Japan. key were there And and some handoff. Europe that especially countries concentrated we that the really with in that, for So wanted to

in So scope it's arrangement. the limited much prior than more

the fee is fee is do the original fee. the is high digits. fee, materially addition, not original but We than disclose single and In current lower the the it lower, materially in

Soo Romanoff

are pretty mpox. alert If governments seems made trials we inquiries getting are other on mind, now. And the on we POX filing progressing. I more And if like It soon? know from like expect the the U.S. you screen also. in are can markets? don't international then sounds are mpox touch touched we the mean, this It to if you the DRC. new I can

Diem Nguyen

the I'll TPOXX as a targeted need in biotreatment well Tecovirimat on such, long-term or benefit the perspective from entire public a a recognition perspective the broader of the a in the Yes, quite heightened mpox security from maybe smallpox The smallpox but is international I as certainly more address stockpile. of has and outbreaks Clearly, a preparedness and consideration XXXX just level, international as outbreak mpox considerations start driven a from one, health with which from policy at then has market. perspective. inquiries important to, consideration stockpile driving take for -- threats can the and awareness orthopox from

mpox or little in So preparedness think look persisted whether threats, the is intertwined we they of such than another while strain cases facing clade the DRC, volumes in bit the only when as increased you that's rising of received and are who X intentionally cases the about today, the mpox the over particular, of X Jynneos. outbreak but who from X. Mpox of lethal -- in requirements, orthopox a the how prevalence perspective. independent where have people X the we And U.S., who much not we DRC. including they're of which increased number share to also naturally the mpox occurring at new are particularly from not in the in concern strain, vaccinated are whether it clade to or past driven and years, be the consistency XXXX could only a has are potentially dose also smallpox more In

a in were case when importance coming As thinking reminder, line weeks. in quick and clinical are in progressing as globally. the in the mentioned, well, in XXXX DRC results highlights in the top globally. mpox the spreading The monitoring cases This forward PALMXXX Africa trials, of the we clinical mpox look trial before activity concentrated Africa to

from is noted This -- last increased a the patients the July. enrolled we're cases which is substantial our also noted as XXX that call, We observing. of increase highlighting patients the roughly also in STOMP trial of has XXX

of as quite goal closely, supplemental the Assuming We're the monitoring an trial NDA positive with so. as XXXX. our work situation early filing data sponsors this with will MPAC

Operator

Instruction]. [Operator

now Nguyen, Diem time. to the like no call return over Okay, questions back CEO. further there at to are Diem? I'd this

Diem Nguyen

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

SIGA (SIGA) 1 Aug 242024 Q2 Earnings call transcript