Q1 2024 SIGA Technologies Inc Earnings Call

[music].

Unknown Executive: 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 those expressed in the forward-looking statements. SIGA does not undertake any obligation to update 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 its subsequent reports on Form 10-Q and Form 8-K.

Welcome to the <unk> business update call before we turn the call over to Speaker. Many Schmidt. Please note that any forward looking statements made during this call are based on management's current expectations and observations.

Unknown Executive: And are subject to risks and uncertainties that could cause actual results to differ from the forward looking statements.

Unknown Executive: Secret does not undertake any obligation to update publicly any forward looking statement to reflect events or changed 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.

Unknown Executive: On the Form 10-K for the year ended December 31, 2023, and its subsequent reports on Form 10-Q and form 8-K.

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

Speaker Change: Good afternoon, everyone and thank you for joining today's call and review of our business results for the first quarter of 2024.

Unknown Executive: I am joined by Dan Luck Shire, our Chief Financial Officer, and we are pleased to have this opportunity to provide an update on our company.

Unknown Executive: After the update we will be happy to answer your question.

Unknown Executive: Overall, SIGA delivered a strong quarter as our team continues to execute at a high level. Our performance reflects the strength of this team, the value of our T-POX franchise, and the steps we're taking to advance our strategy. In the first quarter, SIGA reported product revenues of $24 million and a pre-tax operating income of $11 million, both up over the comparable quarter of 2023.

Speaker Change: Overall pretty good.

Unknown Executive: Delivered a strong quarter as our team continued to execute on a high level.

Unknown Executive: Our performance reflects the strength of this team the value of our <unk> franchise and the steps, we're taking to advance our strategy.

Unknown Executive: In the first quarter CDO reported product revenues of 24 million at a pre tax operating income of $11 million.

Unknown Executive: Both up over the comparable quarter of 2023.

Unknown Executive: These revenues were generated from the delivery of oral teapots in connection with orders placed by the U.S. and certain international governments. We are working diligently to sustain this positive momentum throughout the remainder of the year. We believe 2024 is lining up to be another year of strong financial performance. A central reason for our confidence is our expectation that we will receive another ORA TPOCS order in the near term under the current BARDA contract. In addition to generating strong, durable financial results, we are focused on positioning SIGA for long-term success through our strategic choices.

Unknown Executive: These revenues were generated from Doe.

Unknown Executive: Library of oral cheap Pax in connection with orders placed by the U S.

Unknown Executive: And certain international government.

Unknown Executive: We are working diligently to sustain this positive momentum throughout the remainder of the year.

Unknown Executive: We believe 2024 is lining up to be another year of strong financial performance.

Unknown Executive: Our central reason for our confidence is our expectation that we will receive another or a <unk> order in the near term under the current BARDA contract.

Unknown Executive: In addition to generating strong durable financial results. We are focused on positioning <unk> for long term success through our strategic choices.

Unknown Executive: Executing on Key Operating Initiatives and Exercising Discipline Capital Management. We are doing this through four initiatives to drive shareholder value. Number one, continuing our partnership with the U.S. government. 2, Advancing the Regulatory Approvals of TPOCs and New Indications and Formulations. 3.

Unknown Executive: Executing on key operating initiatives.

Unknown Executive: And exercising disciplined capital management.

Unknown Executive: We're doing this there are four initiatives to drive shareholder value.

Unknown Executive: Number one continuing our partnership with the U S government.

Unknown Executive: Two advancing the regulatory approvals of <unk> in new indications and formulations.

Unknown Executive: Cultivating the Strategic Partnership to Expand Global Access to TPOC and leveraging our capabilities to move into complementary therapeutic areas. This quarter, we made progress on several fronts. A key development took place in April when we amended our agreement with Meridian Medical Technologies for the international promotion of TPox, effective June 1st, 2024. This move not only enables us to control the marketing and promotion of oral teapots outside the U.S., but it also enhances our ability to connect and serve our customers more effectively and seamlessly.

Unknown Executive: Three cultivating the strategic partnership to expand global access to park.

Unknown Executive: And for leveraging our capabilities to move into complementary therapeutic area.

Unknown Executive: This quarter, we made progress on several fronts.

Unknown Executive: A key development took place in April when we amended our agreement with the Meridian Medical technologies for the International show promotion of <unk> effective June one of 2024.

Unknown Executive: This move not only enables us to control the marketing and promotion of royalty parked outside the U S.

Unknown Executive: Also enhances our ability to connect and serve our customers more effectively and seamlessly.

Unknown Executive: Additionally, we strengthened our leadership by appointing a new Vice President of International Markets who brings a wealth of pharma experience, including procurement for international governments and sales and marketing to private industry leaders. We believe this more focused approach will grow and strengthen our international presence, which is crucial amid the rising orthopoxviruses threat. In Japan, our partner, Japan Biotechno Pharma, announced in April that it filed a new drug application for TPOX for the treatment of smallpox, mpox, cowpox, and complications due to the Vicinia virus.

Unknown Executive: Additionally, we strengthened our leadership by appointing a new vice President of International market, who brings a wealth of pharma experience, which includes procurement to international governments and sales and marketing to private industry leaders.

Unknown Executive: We believe this more focused approach will grow and strengthen our international presence, which is crucial amid rising orthopoxvirus threats.

Unknown Executive: In Japan, our partner, Japan, Biotech know pharma announced in April that have filed a new drug application for <unk> for the treatment of smallpox and park cowpox and complications due to the virus.

Unknown Executive: If approved, we anticipate the TPOX will be placed in a national stockpile, ready for deployment in the event of an MPOX outbreak. Consistent with standard practices, we expect to receive an update on the filing early in the third quarter.

Unknown Executive: If approved we anticipate the <unk> will be placed on national stockpile ready for deployment.

Unknown Executive: And pox outbreak.

Unknown Executive: Consistent with standard practices, we expect to receive an update in the filing early in the third quarter.

Unknown Executive: We also continue to advance our efforts to expand TPOCS approvals and new indications and formulations, particularly with our PEP and MPOCS programs. First, on PEP, as stated last quarter, we believe that TPOX has the potential to benefit smallpox patients in prophylactic situations. This use is consistent with how the U.S. Department of Defense is authorized to deploy T-POCs today under the Extended Access Protocol for its personnel.

Unknown Executive: We also continue to advance our efforts to expand <unk> pox approvals of new indications and formulations.

Unknown Executive: Particularly with our Pep and pox program.

Unknown Executive: First on pet.

Unknown Executive: David last quarter, we believe that <unk> has the potential to benefit smallpox patient and prophylactic situations.

Unknown Executive: This view is consistent with how the U S Department of defense is authorized to deploy pops today under the expanded access protocol for its personnel.

Unknown Executive: In short, we've successfully completed the FDA's requirements to obtain extended safety data in humans for 28 days. This trial confirmed TPOC's existing strong safety profile. We also completed a JYNNEOS T-POX immunogenicity trial to evaluate T-POX when administered by administrators who are committed to JYNNEOS. The FDA requested we run this trial because, in the event of an outbreak, TPOX treatment would likely be used in combination with the smallpox vaccine to reduce the morbidity and mortality in the population without sacrificing patient safety.

Unknown Executive: In short we successfully completed the fda's requirements to obtain extended safety data in humans with treatment for 28 days.

Unknown Executive: This trial confirmed <unk> pox existing strong safety profile.

Unknown Executive: We also completed at Jennie O T Pax Immunogenicity trial to evaluate <unk> when administered concomitantly with Jennie O.

Unknown Executive: The FDA requested we run this trial because it in an event of an outbreak teapot straightforward would likely be used in combination with smallpox vaccine.

Unknown Executive: Reduce the morbidity and mortality in the population without sacrificing patient safety.

Unknown Executive: We'll continue to work with the CDC on the collection and analysis of the data from this trial, in consultation with FDA, and expect greater visibility on the path forward in the coming weeks. At the same time, we're working on our supplemental NDA submission and targeting to submit it early next year. Shifting gears to the ongoing MPOCS trials, the sponsors of these trials continue to enroll patients and collect data. In Africa, as of April, the NIAID POM trial being conducted in the Democratic Republic of Congo had enrolled 522 patients.

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

Unknown Executive: Shifting gears to the ongoing <unk> trials the sponsor of these trials continue to enroll patients and collect data.

Unknown Executive: In Africa as of April.

Unknown Executive: Ed I aid Palm trial being conducted in the Democratic Republic of Congo had enrolled 522 patients.

Unknown Executive: A large increase from the 425 patients noted on our last call. In the NIA STOMP trial, as of April, there were 350 patients, which is also a substantial increase from the 267 patients noted on our last call.

Unknown Executive: Large increase from the 425 patients noted on our last call.

Unknown Executive: And the NIH trial as of April there were 350 patients, which is also a substantial increase from the 267 patient noted in our last call.

Unknown Executive: Before proceeding, I'd like to acknowledge the concerning increase in MPOPS cases, particularly in the DRC, where the government recently declared an epidemic. The CDC reports that the DRC is experiencing its largest surge of MPOX cases ever recorded, with over 19,000 suspected cases and more than 900 deaths from January 2023 until about a week ago. Furthermore, the predominant strain in the DRC, also known as clade 1, causes more severe illness and death compared to the strain during the 2022 global outbreak.

Unknown Executive: Before proceeding I would like to acknowledge the concerning increase in impact cases, particularly in the DRC, where the government recently declared an epidemic.

Unknown Executive: The <unk> reported that the RFP is experiencing its largest surge of empire cases ever recorded with over 19000 suspected cases and more than 900 deaths from January 2023 until about a week ago.

Unknown Executive: Furthermore, the predominant strain in the DRC also known as clay one causes more severe illness and death compared to the strained during the 2022 global outbreak.

Unknown Executive: Since 2019, SIGA has been supporting investigators and health agencies in the DRC to reduce the devastating impacts of Mpox disease. We have already donated over 500 courses of T-pox capsules and its matching placebo for randomized clinical trial use in the DRC. We continue to monitor this situation actively to provide assistance when possible. Beyond Africa, orthopox viruses continue to permeate around the world.

Unknown Executive: The 2019, Zika has been supporting investigators and health agencies in the DRC to reduce the devastating impact of impasse disease.

Unknown Executive: We have already donated over 500 courses achieve capsules and matching placebo for <unk>.

Unknown Executive: Randomized clinical trial used in the DRC.

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

Unknown Executive: Beyond Africa Orthopoxvirus has continued a permanent hit around the world.

Unknown Executive: We are committed to working closely with MPOX trial sponsors to complete their trials and analyses as quickly as possible to achieve the best possible outcome for MPOX patients. As a reminder, in Europe and the UK, TPOX, known as tecovirumab, SIGA, has a broad label and has been approved to treat smallpox, mpox, cowpox, and complications following vaccination against smallpox. In the U.S. and Canada, T-pox has been approved for the treatment of smallpox, with ongoing trials for mpox and PET, as discussed earlier.

Unknown Executive: We're committed to working closely with empower trial sponsors to complete their trials.

Unknown Executive: The analyses as quickly as possible to achieve the best possible outcome for <unk> patients.

Unknown Executive: As a reminder, in Europe, and the U K <unk> known as <unk> has a broad label and has been approved to treat smallpox and pox cowpox and complications following vaccination against smallpox.

Unknown Executive: In the U S and Canada Kapok says have been approved for the treatment of smallpox with ongoing trials for <unk> and Pat as discussed earlier.

Unknown Executive: With regard to the important U.S. market, as we look forward to fulfilling any remaining oral TPOX orders under our current contracts to supply TPOX to the U.S. strategic national pile, we are ready to work in close collaboration with the U.S. government on the next contract for S&S stockpileing. Our partnership with the U.S. government spans over a decade with contracts totaling about one billion and reinforces our collective commitment and responsibility to health security.

Unknown Executive: With regard to the important U S market as we look forward to fulfilling any remaining oral <unk> orders under our current contract to supply <unk> to the U S strategic national pile.

Unknown Executive: We are ready to work in close collaboration with the U S government and the next contract for SLS stockpiling.

Unknown Executive: Our partnership with the U S government spans over a decade with contracts totaling about $1 billion and reinforces our collective commitment our responsibility to health security.

Unknown Executive: We are confident in our ability to provide superior value to the U.S. government and collaborate with them to achieve the best outcome for public health security, SIGA shareholders, and patients. Our aim is to secure a long-term contract with annual purchases that reflect TPOC's value today and in the future with a potentially expanded label. As a reminder, smallpox remains a Category A bioterrorism agent according to the CDC, and a recent report issued by the National Academies of Sciences, Engineering, and Medicine titled Future State of Smallpox Medical Countermeasures concluded that this action is needed to enhance U.S. readiness for smallpox and related diseases, as well as to improve diagnostics, vaccines, and therapeutics that can be used in response to an outbreak.

Unknown Executive: We're confident on our ability to provide superior value to the U S government and collaborate with them to achieve the best outcome for public health security Diego shareholders and patients.

Unknown Executive: Our aim is just care a long term contract with annual purchases the reflect <unk> value today and in the future with a potentially expanded label.

Unknown Executive: As a reminder, smallpox remains a category a bioterrorism agent according to the CDC.

Unknown Executive: And a recent report issued by the National Academy of Sciences, Engineering, and medicine titled Future State of a smallpox medical countermeasures concluded that this action is needed to enhance U S readiness for smallpox and related diseases.

Unknown Executive: As well as to improve diagnostics vaccines and therapeutics that can be used in response to an outbreak.

Unknown Executive: The COVID-19 pandemic and the 2022 impacts outbreak highlighted opportunities for strengthening the U.S. public health care system in response to future health threats. We are prepared to do our part as we believe effective therapies and vaccines are essential to combat an outbreak, whether naturally occurring, accidental, or intentional. Overall, our company is strong and profitable, supported by a robust strategy, a disciplined approach to capital management, a valuable TPOX franchise, and a resilient team with proven operational capabilities.

Unknown Executive: The COVID-19, pandemic and the 2022 and pox outbreak highlighted opportunities for strengthening the U S public health care system in response to future health threat.

Unknown Executive: We are prepared to do our part as we believe effective therapies and vaccines are essential to combat an outbreak.

Unknown Executive: Naturally occurring accidental or intention at all.

Unknown Executive: Overall, our company is strong and profitable supported by a robust strategy a disciplined approach to capital management, Evaluable <unk> franchise, and a resilient team with proven operational capabilities.

Unknown Executive: We are executing our strategy with urgency while maintaining our focus on advancing public health. Combined, we believe this will enhance shareholder value over time. With that, I'll turn over to Dan to review the financial results in more detail.

Unknown Executive: We are executing our strategy with urgency, while maintaining our focus on advancing public health.

Dan: We believe this will enhance shareholder value overtime.

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

Dan: Thanks, Dan.

Daniel J. Luckshire: As noted earlier in the call, SIGA's financial results for the three months ended March 31, 2024, substantially surpassed the financial results for the comparable quarter in 2023. Product sales for the three months ended March 31, 2024, were approximately $24 million, in comparison to approximately $6 million of product sales in the comparable 2023 time period. Product sales in the first quarter of 2024 were related to deliveries of oil teapots to a diverse mix of customers.

Dan: As noted earlier in the call.

Daniel J. Luckshire: <unk> financial results for the three months ended March 31 2024.

Daniel J. Luckshire: Statutory surpassed the financial results for the comparable quarter in 2023.

Daniel J. Luckshire: <unk> sales for the three months ended March 31, 2024 were approximately $24 million.

Daniel J. Luckshire: In comparison to approximately $6 million of product sales in the comparable 2023 time period.

Daniel J. Luckshire: Product sales in the first quarter 2024 related to deliveries royalty pox two of <unk>.

Daniel J. Luckshire: <unk> mix of customers.

Daniel J. Luckshire: Approximately $60 million of oil cheap ox was delivered to the U.S. government, including $15 million of deliveries to the U.S. Strategic National Stockpile and a $1 million delivery to the U.S. Department of Defense, and approximately $8 million worth of world teapots were delivered to eight international customers, but seven of those customers were located in Newark.

Daniel J. Luckshire: <unk> $16 million of oil G box was delivered to the U S government.

Daniel J. Luckshire: Including $50 million of deliveries to the U S strategic national stockpile.

Daniel J. Luckshire: The 1 million Talbot deliberate should the U S Department of defense.

Daniel J. Luckshire: And approximately $8 billion grilled cheese products, whilst deleveraging eight international customers.

Daniel J. Luckshire: With 70 of those customers located in Europe.

Daniel J. Luckshire: Pre-tax operating income, which excludes interest income and taxes, was approximately $11 million for the first quarter of 2024. In comparison, there was a pre-tax operating loss of approximately $2 million in the comparable period in 2023. Net income for the first quarter of 2024 was approximately $13 million, versus a net loss of approximately $1 million in the first quarter of 2023. In turn, fully diluted earnings per share for the first quarter of 2024 was $0.14, versus a comparable fully diluted loss per share of OneChain in the first quarter of 2023.

Daniel J. Luckshire: Pre tax operating income, which excludes interest income taxes was approximately $11 million for the first quarter of 2024.

Daniel J. Luckshire: In comparison, there was a pretax operating loss of approximately $2 million in the comparable period in 2023.

Daniel J. Luckshire: Net income for the first quarter of 2024 was approximately $13 million.

Daniel J. Luckshire: Versus a net loss of approximately $1 million in the first quarter of 2023.

Daniel J. Luckshire: In turn <unk>.

Daniel J. Luckshire: Income per share for the first quarter of 2024 was 14 said.

Daniel J. Luckshire: First as a comparable fully diluted loss per share.

Daniel J. Luckshire: One.

Daniel J. Luckshire: In the first quarter 2023.

Daniel J. Luckshire: At March 31st, 2024, the company continued to maintain a strong balance sheet with a cash balance of approximately $144 million and no debt. On April 1st, SIGA paid the previously disclosed special cash dividend of $0.60 per share, which amounted to an approximately $43 million payment to shareholders.

Daniel J. Luckshire: At March 31, 2024, the company continues to maintain a strong balance sheet with a cash balance of approximately $144 billion and no debt.

Daniel J. Luckshire: On April one so.

Daniel J. Luckshire: <unk> paid the previously disclosed special cash dividend of <unk> 60 per share.

Daniel J. Luckshire: Which amounted to an approximately $43 million payment to shareholders.

Unknown Executive: Looking forward, as mentioned by them earlier in the call, we are working diligently to continue our positive momentum. As such, we believe 2024 is lining up to be another year of strong financial performance, based on our expectation that we will receive another World Teapots order in the near term under the current BARDA contract. This concludes the financial update. At this point, I will turn the call back to Zen.

Daniel J. Luckshire: Looking forward as mentioned by Jim earlier in the call.

Unknown Executive: We are working diligently to continue our positive momentum.

Unknown Executive: As such we believe 2024 is lining up to be another year of strong financial performance.

Unknown Executive: Based on our expectation that we will receive another world <unk> water in the near term under their current BARDA contract base.

Unknown Executive: This concludes the financial update.

Unknown Executive: At this point I will turn the call back to Jay.

Unknown Executive: Thanks, Dan. With that, I'll end where I began. SIGA delivered a strong quarter as our team continued to execute at high levels. We remain focused on positioning SIGA for long-term success for the benefit of our patients, partners, and shareholders. Now I would like to open the call to Q&A. Operator? Thank you. Ladies and gentlemen, we will now begin the question.

Zen: Thanks, Dan with that I'll end, where I began so you have delivered a strong quarter as our team continued to execute at high levels.

Unknown Executive: We remain focused on positioning <unk> for the long term success for the benefit of our patients partners and shareholders now.

Unknown Executive: Now I would like to open the call to Q&A operator.

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the 1 on your telephone keypad. You will hear a three-tone prompt acknowledging your request. Questions will be taken in the order received. Should you wish to cancel your request, please press star followed by 2. If you are using a speakerphone, please lift the handset before pressing any keys.

Unknown Executive: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by one on your telephone keypad.

Operator: <unk> III Donald Trump's technology request.

Operator: Questions will be taken into or would you receive should you wish to cancel your request. Please press star followed by the two if you're using a speaker phone. Please lift the handset before pressing any keys.

Operator: One moment, please for your first question. Once again, dial the star and 1 to ask a question. And your first question comes from the line of Soo Romanoff from Edison Group. Please go ahead.

Speaker Change: One moment. Please for your first question.

Operator: Yes.

Soo Romanoff: Once again that is star and want to ask a question.

Operator: And your first question comes from the line of Soo Romanoff from Edison Group. Please go ahead.

Soo Romanoff: Hi, great quarter. Congratulations, everybody.

Soo Romanoff: Hi, great quarter, congratulations everybody, it's nice to see.

Soo Romanoff: Lot of things kind of.

Unknown Executive: It's nice to see a lot of things kind of lining up as we were hoping. My first question was about the BARDA contract. I believe we had $112 million for oral TPOCs and $26 million for IV TPOCs. And it seems like we got a big chunk of that this time. And we had some, maybe some manufacturing challenges before, but it seems like we've kind of worked that out. Do we expect the balance of that to come in in 2024, I assume, or is there going to be any spillover into 2025?

Soo Romanoff: Lining up as we were hoping.

Unknown Executive: My first question was on the.

Unknown Executive: On the BARDA contract.

Unknown Executive: Believe we had $112 million.

Unknown Executive: And for oral.

Unknown Executive: T <unk> and $26 million for IV <unk>.

Unknown Executive: <unk> and it seems like we got a big chunk of that this time.

Unknown Executive: And we had some maybe some manufacturing challenges before but it seems like we've kind of worked that out.

Unknown Executive: Do we expect the balance of that to come in in 2020 for I assume or is there going to be any spill over into 2025.

Daniel J. Luckshire: Right, this is Dan. Thanks for the question. In terms of, well, I guess there's, there's two parts to your question in terms of you did mention the vendor packaging issues in 23. So we have been working with the packaging vendor in terms of smoothing out that process and really getting back into the rhythm that we had prior to 2023. This is a long-standing vendor, and historically, it was relatively smooth. However, we did have a hiccup.

Unknown Executive: Right. This is Dan thanks for the question in.

Daniel J. Luckshire: In terms of well I guess there is there is two parts of your question in terms of you did mention the.

Daniel J. Luckshire: The vendor packaging issues in 'twenty three so we are we have been working with the packaging vendor in terms of smoothing out.

Daniel J. Luckshire: That process and really getting back into a rhythm that we had prior to 2023 as background. This is a long standing vendor and historically is relatively smooth.

Daniel J. Luckshire: We did have a hiccup.

Daniel J. Luckshire: Toward the end of last year, we have been working with them to smooth it out and really be prepared as much as possible for what we anticipate to be an upcoming order. So with that, in terms of talking about specificity about timing of deliveries, in terms of 2024 versus 2025. It's probably a little premature to really comment on specificity on whether all the orders will be delivered in 2024. Having said that, the reason we say that is it's not just the packaging vendor, but also other considerations such as when the order comes in and when and where the government wants deliveries.

Daniel J. Luckshire: Towards the end of last year. So we have been working with them to smooth it out and really be prepared as much as possible for what we anticipate to be.

Daniel J. Luckshire: In the upcoming quarter.

Daniel J. Luckshire: So with that in terms of.

Daniel J. Luckshire: Talking about specificity about timing of deliveries.

Daniel J. Luckshire: In terms of 2024 versus 2025.

Daniel J. Luckshire: It's probably a little premature to really comment on specificity.

Daniel J. Luckshire: On whether all the.

Daniel J. Luckshire: Yes.

Daniel J. Luckshire: There will be delivered in 2024.

Daniel J. Luckshire: Having said that the reason we say that is it's not just.

Daniel J. Luckshire: The packaging vendor, but also the other considerations are as when the order comes in and when and where the government wants deliveries. So there is a series of variables. So as we get further in the year, we'll have a little more clarity on the details there I would like to highlight that as we noted in our prepared remarks.

Daniel J. Luckshire: So there are a series of variables. As we get further into the year, we'll have a little more clarity on the details there. I would like to highlight, though, that as we noted in our prepared remarks, we do anticipate an order, and we do believe that 2024 is lining up to be a strong year financially based on our expectations. And so we do think it will be substantial, but in terms of specificity, we'll have to get back to you.

Daniel J. Luckshire: We do anticipate an order and we do believe that 2024 is lining up to be a strong year financially based on our expectations.

Daniel J. Luckshire: And so we do think it will be substantial but in terms of specificity.

Daniel J. Luckshire: To get back to you.

Unknown Executive: Okay, thank you. That's really helpful. And then, like with the Meridian contract, I know that there are some amended terms for international distribution. Could you help me understand how that works now? I mean, I think previously the Meridian fee was around 20% of sales, and the revised fee figure for the new contract might be a little different.

Speaker Change: Okay. Thank you that's really helpful. And then also like on the Meridian contract I know that there is.

Unknown Executive: So amended terms for the international distribution.

Unknown Executive: Could you help me understand.

Unknown Executive: How that works now.

Unknown Executive: Previously the Meridian for you is around 20% of sales.

Unknown Executive: Right.

Unknown Executive: Revise the figure for the new contract.

Unknown Executive: Internationally might be a little different.

Unknown Executive: Let me take that question. First, let me start by highlighting that the amendment is strategically important and that it enhances our ability to connect and serve our customers more effectively and seamlessly. Regarding the terms of the amendment, effective June 1st, 2024, there will be a high single-digit fee percentage for international sales in the European Economic Area, Australia, Japan, Switzerland, and the United Kingdom. If I were to summarize, I would say first, we were able to reduce the scope of the international sales that would be subject to a fee and, second, reduce the fee percentage for those sales that are subject to a fee.

Speaker Change: So let me take that question. So first let me start by highlighting that the amendment is strategically important.

Unknown Executive: That it enhances our ability to connect to serve our customers more effectively.

Unknown Executive: And seamlessly.

Speaker Change: Regarding the terms of the amendment.

Unknown Executive: Effective June one 2024, there will be a high single digit fee percentage for international sales in the economic.

Unknown Executive: European Economic area, Australia, Japan, Switzerland, and the United Kingdom.

Unknown Executive: If I were to summarize I would say first we were able to reduce the scope of the international sales that would be subject to fee and second reduce the fee percentage for those sales that are subject to a fee.

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

Unknown Executive: International sales other than those in the European Economic area, Australia, Japan, Switzerland, and the United Kingdom will not have a fee.

Unknown Executive: Quite enthusiastic about our ability to play a more direct role in international sales and confident of our ability.

Speaker Change: That's great news.

Soo Romanoff: That's amazing. Thank you for answering my questions and congratulations again on a great quarter.

Speaker Change: Amazing. Thank you for answering my questions and congratulations again on the great quarter.

Operator: Thank you. Once again, that is a star and one to ask a question. Your next question comes from the line of Bryan Adams from Heart 30. Please go ahead.

Speaker Change: Thank you once again that is star in one geography question.

Brian Adams: Your next question comes from the line of Brian Adams from Hartford, Sorry. Please go ahead.

Bryan Adams: Yes, hi, again. I just want to reiterate a great quarter for you guys. A couple quick questions. Just for clarification, this: when you speak of the upcoming fulfillment of the BARDA contract, I'm assuming that's the fourth and final tranche of the original agreement, is that correct?

Brian Adams: Yes, Hi, again, I, just want to reiterate great quarter for you guys.

Brian Adams: Couple of quick questions.

Brian Adams: Just for clarification.

Bryan Adams: This.

Brian Adams: When you speak of the upcoming.

Bryan Adams: Fulfillment of the border.

Brian Adams: Contract I'm, assuming that's the fourth and final tranche of the original agreement is that correct.

Unknown Executive: Yes, you're correct in that for Oral-T-Pox, there are four options for $113 million each, and this would be the fourth and final option within the current contract.

Brian Adams: Yes, Youre correct in that there is two royalty Pax there's four.

Unknown Executive: Options for $113 million, each and this would be the fourth.

Speaker Change: Final option within the current contract.

Bryan Adams: Okay, so now Beggs, the question is, are you in early talks to do a Part B or a secondary run of the teapots for the Defense Department, and is that a discussion that would be happening now and then also would potentially be on track for some time in late Q4 of 25 or the first part of 26, based upon the cadence of how the orders have been filled at the time.

Unknown Executive: Sure.

Unknown Executive: So it begs the question are you in early talks to.

Bryan Adams: Do have a part b or a secondary.

Bryan Adams: Ron.

Bryan Adams: The <unk> for the.

Bryan Adams: Our defense Department and.

Bryan Adams: Is that a discussion that would that would be happening now and then also would potentially be on track for some time in late Q4, 'twenty fiber first part of 'twenty six.

Bryan Adams: Based upon the cadence of how the orders have been filled.

Bryan Adams: Time passed.

Unknown Executive: Thanks, Brian. Although we haven't yet received notice from the Administration of Strategic Preparedness and Response about its plans for issuing another RFP for the US national stockpile, we are preparing for it sometime this year. Our aim is to secure a long-term contract with annual purchases that reflect the value of TPOC provided today as well as a feature based on the potentially expanded label, which will include MPOCS as well as PEP.

Thanks: Thanks, Brian.

Bryan Adams: Although we haven't yet received notice from the administration of strategic preparedness and response about its plans for issuing another RFP for the us national stockpile, we are preparing for it sometime this year.

Unknown Executive: Our aim is to secure a long term contract with annual purchases that reflect the value of <unk>.

Unknown Executive: Provided today as well as the future based on the potential expanded label, which will include <unk> as well as pet.

Bryan Adams: Okay, and then just a secondary question. With the STOMP trial, which has been going on for a good 18 months or so, is it, not to put words in your mouth, do you feel somewhat frustrated with, you know, the results and how long some of the, you know, how long this has taken as far as getting results and, you know, any kind of color or comment from the FDA on this?

Unknown Executive: Okay.

Unknown Executive: Then.

Unknown Executive: A secondary question.

Bryan Adams: With the Stomp trial, which has been going on for a good 18 months or so is it.

Bryan Adams: Okay.

Bryan Adams: Not to put words in your mouth, you feel somewhat frustrated.

Bryan Adams: The results of how long somebody here.

Bryan Adams: How long this has taken as far as getting results in any kind of color or comments from the FDA on this.

Bryan Adams: From.

Unknown Executive: From the STOMP trial perspective, as noted, it is sponsored by NIAID and has enrolled over 350 patients as of April, so there has been a substantial increase from what we noted from our last call. April 2024 was the highest recruitment month to date for the STOMP trial, which is currently enrolling roughly 50 patients per month, so we're not at all frustrated with the pace given the fact that we're seeing high recruitment.

Bryan Adams: From the Stomp trial per se.

Speaker Change: As noted.

Unknown Executive: It is sponsored by the NIH and has enrolled over 350 patients as of April. So there has been a substantial increase from what we noted from our last call.

Unknown Executive: April 2024 was the highest recruitment month to date for the start trial, which is currently rolling about roughly 50 patients per per month. So we're not at all frustrated with the pace given the fact that we're seeing high recruitment.

Unknown Executive: As it relates to current FDA guidance on target enrollment, the study will be fully enrolled in 2025. However, we would caution that there are a lot of variables that will impact timing until recruitment is complete. However, we are working closely with our partners to file with FDA as soon as we can.

Unknown Executive: As it relates to.

Unknown Executive: Current FDA guidance on target <unk>, the study will be fully enrolled in 2025.

Unknown Executive: We would caution that there is a lot of variables that will impact timing until recruitment is complete. However, we are working closely with our partners to file with FDA. The FDA as soon as we can.

Unknown Executive: Okay.

Bryan Adams: All right, thank you for the questions. Thank you. Great quarter.

Speaker Change: Alright, Thank you for the question.

Speaker Change: At a time, thank you great great quarter appreciate it.

Speaker Change: Thank you.

Unknown Executive: Thank you. Ms. Nguyen, there are no further questions at this time. Please proceed.

Speaker Change: Thank you Ms. Zhang when there are no further questions at this time. Please proceed.

Unknown Executive: Thanks, Operator. I'd like to thank everyone for making time to join us on today's call and for your ongoing interest in SIGA. We really look forward to speaking to you again on our second quarter call.

Diem Nguyen: Thanks, operator, I'd like to thank everyone for making time to join US on today's call and for your ongoing interest and Seeger, We really look forward to speaking to you again at our second quarter call have a good rest of the evening.

Unknown Executive: Have a good rest of the evening. Thank you. This concludes today's call. Thank you for participating. You may all disconnect.

Speaker Change: Thank you. This concludes today's call. Thank you for participating you may all disconnect.

unknown: [inaudible]

unknown: Okay.

unknown: Okay.

unknown: Okay.

unknown: Okay.

unknown: [music].