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spk06: FIGA 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 13th, 2021. Excuse me, 2021. and its subsequent reports on Form 10Q and Form 8K. With that said, I'd like to turn the call over to Mr. Phil Gomez, your host.
spk10: Thank you for taking the time to join today's call. Today I'm joined by Dan Luckshire, our CFO, and Dr. Dennis Ruby, our CSO. We are pleased to have this opportunity to provide a business, R&D, and financial update to our shareholders. We'll then be happy to take questions. With the global monkeypox outbreak, we've been very busy over the last approximately 75 days responding to inquiries from a broad multitude of people and entities across the public health ecosystem, as well as building on existing governmental and public health relationships. One initial result of this activity has been a significant increase in the international procurement orders this year versus 2021, with approximately $60 million of oral TPOCs orders from 10 international jurisdictions this year through July 31st, in comparison to approximately $13 million of international orders last year. Of the 10 international jurisdictions who have ordered oral TPOCs in 2022, nine of the jurisdictions are first-time customers in 2022. We believe that the increasing number of international governments that are procuring oral TPOCs in addition to the large number of continuing inquiries regarding TPOX usage for monkeypox in its potential procurement, highlight two key elements. Firstly, that is essential that governments across the world adopt a more proactive approach to addressing the health risks posed by families of viruses, such as the orthopoxvirus family. And secondly, that TPOX is a significant component to any robust public health program designated to protect against orthopoxvirus risks and threats. With respect to the monkeypox outbreak, the sheer magnitude of inquiries and usage requests and the oftentimes frenetic manner of such inquiries highlight the seriousness of the outbreak, both currently and for what the outbreak could become. The recent WHO designation of the monkeypox outbreak as a public health emergency of international concern reinforces the serious nature of the outbreak and its potential. Right now, it is early innings, to use a baseball analogy. the number of global cases of monkeypox has quickly grown to more than 25,000 cases. And there are anecdotal reports that the breadth of transmission appears to be expanding. At this early stage, we are in the same spot as the public health community in that we have much more to learn in order to get a better sense of what to expect with regard to the ultimate scale and scope of the monkeypox cases to come. Based on what we've learned so far, we believe the following is clear. First, monkeypox is a severe disease. As case reports and patient stories have made clear, an infection can have significant consequences. Patients are experiencing severe pain, scarring, and hospitalization to manage the complications of the disease when antiviral therapy is not available. Second, quarantines that require three weeks or more have significant impact on patients who cannot work or interact with family members. Third, although currently focused in the social networks of the men having sex with men or MSM community, Most experts do not anticipate the outbreak will be limited to this population. In other words, it is likely the virus will spread to a variety of segments and real life examples of this are growing. Fourth, vaccines alone cannot mitigate this outbreak. Supply challenges, vaccine hesitancy and ongoing cases require both vaccination and treatment to address the impact. Fifth, The outbreak has highlighted the importance of stockpiling of teapots to mitigate the impact of orthopoxvirus outbreak. Procurement by governments after an outbreak takes too long for governments to be able to access the drug. And six, the population needs better access to teapots. In sum, we believe the monkeypox outbreak is a clarion call to governments to increase the pace of building stockpiles for smallpox and monkeypox where none exist, and of resizing and expanding stockpiles that do exist. As such, we will continue to pursue, in coordination with international promotion partner Meridian Medical Technologies, tangible procurement activity in regions and countries in which monkeypox continues to grow and or become endemic. In addition to being a catalyst for international procurement orders, the monkeypox outbreak has also been a catalyst for opportunities to enroll patients in trials being planned for oral TPOC. This is important because collecting data from trials and from usage in the population is a key focus point for us as we pursue monkeypox approval with the FDA, which is one way to get better access to TPOX for monkeypox patients. As background, the FDA has indicated that it wants efficacy data in the treatment of monkeypox for full approval of TPOX in the U.S. for the monkeypox indication. Dennis will discuss the trial opportunities in a few minutes. Before I hand over the call to Dennis, I would like to touch on a few achievements over the past series of months. On the regulatory front, the IV formulation of TPOX was approved by the FDA in May, and oral TPOX was approved in July by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the United Kingdom. With these approvals, we have now achieved four regulatory approvals for TPOX in the approximate span of little more than half a year. The other regulatory approvals being the oral TPOX approval by the European Medicines Agency, EMA, in January, and Health Canada approval in December 2021. I will note that the EMA and MHRA approvals include broad labeling for oral TPOCs, indicating its use for the treatment of monkeypox, smallpox, cowpox, and vaccinia complications following vaccination against smallpox. All of these regulatory approvals were based on animal efficacy data, with human clinical trials conducted to demonstrate safety and pharmacokinetics consistent with the levels that protected non-human primates. Those studies published by Dennis in the New England Journal of Medicine in 2018 showed over 90% protection from death in a lethal challenge model. During an outbreak, whether smallpox or monkeypox, we always anticipated collecting confirmatory efficacy data in humans. Dennis will provide an update on the clinical trials being planned or ongoing to collect the data. These clinical trials are important as they are focused on broader use of TPOX in outpatient settings. The data in non-human primates showed that treatment with TPOX stopped progression of the disease and reduced viral shedding. We believe these studies will provide a basis for approval in the U.S. for monkeypox and support for wider use of TPOX to treat a broader set of patients presenting with the infection. On the procurement front, we signed our first procurement contract with the U.S. Department of Defense in May. The procurement contract is for approximately $7.5 million of oral teapots, of which approximately half was delivered in the second quarter, and we expect the option for the other half to be likely exercised in 2022. Additionally, we believe there will be opportunities to add to this procurement. One way this procurement is important is that it continues to expand our revenue base. As a reminder, our revenue base expanded in the first quarter when we made our first deliveries of intravenous teapots to the U.S. government. At this point, I'd like to hand the call over to Dennis Ruby, who will provide a regulatory and R&D update, including details on the PEP clinical program. Dennis?
spk08: Thank you, Phil. I will start my comments with an update on post-exposure prophylaxis, or PEP, clinical trials, and then I will comment on the monkeypox outbreak and the oral TPOX trials in connection with the treatment of monkeypox. With respect to PEP, as a reminder, we're working with our DOD colleagues on executing two clinical trials needed to support regulatory approval of TPOX for post-exposure prophylaxis. For the expanded safety study, we have set up nine clinical sites around the US, and these sites began dosing mid-quarter. I would characterize enrollment as being also a substantial and strong start. As of the end of July, approximately half the study had been enrolled, with most enrollees having completed the 28-day dosing period. For the TPOXX plus JYNNEOS immunogenicities trial, we have two sites recruiting and screening volunteers. This trial started in early 2022, and enrollment got off to a slow start. This was due in part to post-COVID vaccine hesitancy in the U.S., among other factors. In coordination with the DoD, we've made protocol adjustments and other adjustments so as to normalize the speed of enrollment. Over the past series of weeks, even before the monkeypox outbreak gained a substantial foothold in the U.S., enrollment has begun to improve. With the monkeypox outbreak, we're continuing to work to further enhance enrollment in this trial. For both studies, the goal is to have all the volunteers complete the active phase by late in the third quarter of 2022 or early in the fourth quarter. If the studies show the expected results, we would commence assembly activities for a package requesting regulatory approval of TPOX for PEP. Shifting gears, I'd like to now discuss clinical activity in connection with oral TPOX and monkeypox. We are currently supporting and assisting with launching up to 10 clinical trials in Africa, Europe, and North America to formally assess the effectiveness of TPOX to treat and or prevent monkeypox in human patients. These include both multinational observational studies as well as placebo-controlled research clinical trials. The first of these is launching as I speak, and we hope to quickly accrue data to support potential approval of a monkeypox indication here in the U.S. to facilitate getting drug to those who need it. Before I turn the call over to Dan, I'd like to highlight something that's been mentioned previously in investor calls and earlier today by Phil, which is that we think of TPOX through the lens of being a treatment for the orthopox family of viruses. And we believe the monkeypox outbreak shows the wisdom of this approach. As such, we will continue to look for opportunities and work with our governor partners in pursuit of broad label indications for TPOX whenever possible. With that update, I'll turn the call over to Dan.
spk05: Thanks, Dennis. For the three and six months ended June 30th, 2022, EGIS revenue is approximately $17 million and $27 million, respectively. For the second quarter, approximately $5 million of revenue relates to international sales of oral TPOX. Approximately $4 million relates to sales of oral TPOX to the U.S. Department of Defense, and the remainder relates to research and development activity. In connection with the sales of oral TPOX, both cases were first-time sales to a new customer. For the six months ended June 30th, approximately $7 million of revenue relates to sales of intravenous TPOCs to the U.S. government. Approximately $9 million relates to the aforementioned sales to the Department of Defense and the new international jurisdiction. And the remainder relates to research and development activity. Operating income, which excludes interest income, taxes, and adjustments to the fair value of the warrant, was approximately $3.1 million for the three months ended June 30, 2022. For the six months ended June 30, operating income was approximately $1.6 million. Dead income for the three months ended June 30, 2022, was approximately $2 million. For the six months ended June 30, dead income was approximately $1.7 million. In turn, Fully diluted income per share for the three months ended June 30th, 2022 was 3 cents per share. And for the six months ended June 30th, fully diluted income per share was 2 cents. At June 30th, 2022, the cash balance for the company was approximately $115 million. During the second quarter, Chica declared and paid a special cash dividend of 45 cents per share. Additionally, the company repurchased approximately 25 million shares of its common stock for approximately $3.6 million. As a quick reminder, please note that in addition to using cash for capital management activities, such as the special cash dividend and share repurchases, we expect to use cash to proactively build work and process inventory for active pharmaceutical ingredients. With respect to the $60 million of international orders received this year, as of July 31st, approximately $5 million of these orders were delivered in the second quarter of 2022. Approximately $26 million is expected to be delivered in the third quarter of 2022, and the remaining orders are expected to be fulfilled between October 1st, 2022 and July 31st, 2023. This concludes the financial update. At this point, I will turn the call back to Phil.
spk10: Thanks, Dan. Before we turn to Q&A, I would like to reiterate a few points, many of which have been made in the past in support of our view that Seager offers an attractive combination of existing revenue streams that generate strong financial results when product is ordered and delivered, complemented by organic growth initiatives that hold significant potential when viewed collectively. First, I'd like to reiterate that monkeypox outbreak has heightened the importance of TPOX in connection with the treatment of monkeypox. It is our understanding that TPOX is the leading and likely the only in many countries therapeutic that is being used or expected to be used in the U.S., Europe, Canada, Asia Pacific region, Africa, and other areas. We will continue to work with various levels of the medical community and governments to provide TPOX to monkeypox patients and to pursue appropriate stockpiles. Second, I would like to highlight that the ongoing international sales growth initiative is progressing in a value-creating manner. We now have more than 10 countries, including the U.S., that have ordered TPOCs, and we continue to work hard to expand that base. While, as noted many times before, progress on this front is expected to be lumpy and uneven given a variety of factors, we believe that meaningful international market is gradually taking shape. Third, I want to reiterate that the PEP-based development program represents a growth initiative in that it would provide scientific and regulatory support for any stockpile expansion. As stated on earlier calls, we believe the current size of the stockpile of teapots would not be sufficient to treat all those who would need care in many outbreak scenarios. A lesson from the COVID pandemic, which is being reinforced by the monkeypox outbreak, is that governments need to be more proactive in addressing the health and social risks associated with virus families. Fourth, we continue to be focused on transitioning from our U.S. contract to a long-term S&S contract that focuses on appropriate size requirements for the TPOC stockpile, as well as smoothing the annual deliveries, which would be critical to supply chain planning and financial predictability. Fifth, our portfolio of customers is becoming more diversified. This year, we added the U.S. Department of Defense to our customer list, as well as nine international jurisdictions. Six, we continue to pursue and support oncology collaborations and other strategies that can open up new markets for TPOP. As mentioned earlier, we believe these initiatives, when viewed collectively, have potential for significant value creation. This concludes our prepared remarks, and we will now begin the Q&A session.
spk06: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. As a reminder, if you'd like to ask a question, please press Star 1 on your telephone keypad. One moment, please, while we poll for questions. Our first question comes from Sue Romanoff with Edison Group. Please proceed with your question. Are you there, Sue? Are you muted?
spk02: Yes, sorry about that. That's okay.
spk06: Please proceed with your question.
spk02: Great, thank you. You know, the most interesting thing is your model is pretty, the ability to predict your revenues is pretty easy in the U.S., mainly because of the stockpiles. Could you give us some guidance on anticipated penetration rates or if there are any supply chain restrictions that you anticipate.
spk10: All right, Sue. Thanks so much for your question. As you highlight, in the U.S., there is a 1.7 million-course stockpile. We have discussed and pointed out that that would likely be inadequate in the case of a smallpox outbreak, and our post-exposure program is looking to add that label to increase the availability of that stockpile and the size of it. To the question internationally, it is a very rapidly evolving set of circumstances. So I would say there's two things that are driving our performance that we're reporting today, and it really will be the outbreak that goes forward. So the first part is, unfortunately, I think a lot of public health organizations around the world did not think of monkeypox as a serious threat, even when the first cases came. There was a A lot of statements around limited morbidity, limited mortality, and a bit of a wait-and-see approach, which was unfortunate. For those governments that did pursue it, we also have to go through the procurement process. I'm very excited. We now have nine countries that have procurement mechanisms in place for us to deliver. We have had people make initial orders, which are usually based on the number of cases they have in the immediate area. But we also now have ability for them to do follow-on orders We do see that activity increase. I think the public health emergency declaration in the U.S., along with the WHO's declaration, will help public health officials focus on what is going to be needed for the delivery of product to mitigate this outbreak. And so we stand by the ready to execute those orders and deliver. On the supply side, a couple comments there. We knew that in the U.S. there would be 363,000 courses expiring over the next few years. We know we had European approval. We had delivered 363,000 courses in 2020 and 2021. And for those that may not know, we have a U.S.-based supply chain that has been delivering product to the U.S. Strategic National Stockpile since 2013. So we have the ability with our existing network and their existing capacity to certainly get above the 363,000 courses, certainly above around the 500,000 course a year mark. But it is not a fixed ceiling. It is a network of CMOs that campaign our product. So we have been busy working with the U.S. government in thinking about ways to increase that production and find ways to address the outbreak wherever it ultimately may go. So certainly stay tuned there. The bottom line is, though, we do have product that is in a warehouse. We are shipping against orders that get made. And so we feel like we're in a good position, at least at this point in the outbreak. Of course, that will depend on ultimately the number of courses and the number of cases that we see globally. But we're certainly looking at scenarios to plan for that. So thank you, Sue.
spk02: Yeah. One more question. You know, where are we? I think with the U.S. approval here for monkeypox, it seems like you're getting some positive news directionally, but I was curious if we had any idea of timing on that.
spk10: Just to clarify, Sue, I think you're probably asking about efficacy data in patients. Maybe I'll hand that over to Dennis. It's early innings, but Dennis, do you have any comment there?
spk08: Yeah, the FDA has consistently asked for controlled clinical trials to demonstrate efficacy and safety. before they would grant a monkeypox approval. As you've probably seen, we are in the process of standing up a number of trials around the globe. Importantly, there's one in the U.S. in the Clinical Trials Network, there's one in the U.K., and there's one in Canada. All these are using essentially the same protocols for the same endpoints, and that data should be coming out over the matter of the next few months. As that data accumulates, I think we'll be in a position to apply for an approval for monkeypox here in the U.S.
spk03: Okay. Thank you all.
spk10: Thank you, Sue. I think it's also important to divide two important points. One is an ultimate approval by FDA, a full approval that provides label expansion for monkeypox. And then the second one is access for patients in an outbreak. As we've seen, there's certainly been a challenge around the complexity of the expanded access IND. We've certainly been very supportive in trying to respond to any data requests from FDA to help understand ongoing clinical studies, what's available for that. But as FDA and CDC has said, they're looking to continue to reduce the burden on getting this drug out to those that would need it with monkeypox infection. And I would note Tony Fauci in an interview today said he would like to see that paperwork eliminated. And certainly that has been a call from folks in the public health community, physicians. And I do think the declaration of the public health emergency will continue to put pressure to find the appropriate ways to get access to the drug immediately. As I said, we always knew we would go back and get efficacy data in humans, but that is confirmatory efficacy data. that we know, based on the animal data, is likely to be positive. So it's important to get access to patients. It's important to have folks who are suffering and have the infection get access. And clearly, with the declaration today and the work FDA and CDC are doing, we're encouraged that we'll continue to make progress on that front at FDA and CDC. Thanks.
spk06: Our next question comes from Ben Rapese. with story trading. Please proceed with your question.
spk00: Hi. I got caught off at the beginning of Q&A, so I don't know if you covered this, but can you give me an idea of the opportunity, I guess, in the next 6 to 12 months for smallpox sales versus monkeypox sales? I noticed on Q4 you did over $100 million with that contract with the federal government. So where's the bigger opportunity for you?
spk10: Yeah, it's a great question, Ben, and thank you for asking it. So our revenues, for those of you that may be new to our story, is on the resupply of a current stockpile that's in the US government. The product started to be delivered in 2013. It has a seven year shelf life. So we started to resupply with the US government and there are lumpy options associated with that. So we have four roughly $112.5 million orders that we anticipate that would come between 2020 and 2024. So in 2021 and 2022, we had two orders that would be delivered. As we've said on previous calls, we do not anticipate a high number of expiries this year. So we anticipate starting next year and the year after we would have the similar deliveries on the smallpox front for the US government. Obviously the monkeypox outbreak and the use of the drug could impact that. We think it's important to forward manufacture and get those deliveries in as soon as possible, but that is ultimately up to the US government. Ben, your question on monkeypox is an excellent one. We're monitoring the outbreak closely. I would say a couple things and then maybe hand it to Dennis as we think about it. What I'd reiterate is that it is early innings. It's around scenario planning and thinking how many people could be used using the drug. The studies that are being designed now that are placebo controlled will focus on outpatients, so people who get diagnosed will get treated, not just the severe disease phase of the disease course. So we're going to monitor that carefully. But I do think we think this virus, unfortunately, might be here to stay and become endemic in some regions. But what we can't say and what we're monitoring closely is ultimately what the market opportunity will be and if it will be larger or smaller than the current smallpox market. But this is a family of viruses. And so what is important to remember is whether it's monkeypox, whether it's the Central African clade of monkeypox that has been shown to be up to 10% fatal, whether it's smallpox, whatever it might be,
spk08: um these types of antiviral drugs are critical to have available dennis i don't know if you had anything in on your perspective on the output no no i agree and most experts agree that monkeypox is here to stay i think we're uh underestimating how much disease burden there is currently because of the delay in diagnostics and the prolonged incubation period of the virus we're also starting to see it spread from the current msm population into children and Others were starting to see some deaths. So I think this is not going to go away and it's going to be a significant problem for a significant period of time.
spk00: Great. Just wanted to make sure I heard you correctly. You said not this year, but next year in 2023, you'd expect a similar size order from the government, like we're talking about like 100 million or so?
spk10: That is correct. In 2023 and 2024, there are two essentially options or orders remaining on our existing contract that we anticipate will be executed in 2023 and 2024. Each of those $112.5 million.
spk00: Okay, great. Last question. I wanted to know what your thinking is around the share repurchases. Stocks is up quite a bit. So going forward at these levels, can we expect that to continue? Or how do you think about the value of the company?
spk10: Yeah, I would say that we have – I'd like to say that we have a track record of being very disciplined about our use of cash. Over the past several years, we've done over $60 million in share repurchases. We did a 45-cent special dividend. We continue to look at all uses of cash, whether that be potential M&A to do accretive acquisitions that could bolt on our business, but we've certainly focused on returning cash to shareholders. This outbreak is – has a lot of scenarios as to where it could go. We've been disciplined in the past to make sure we have clarity on where we're going from a cash basis. So we will continue to look at share repurchases, continue to look at dividends, continue to look at the best use of cash. But certainly right now, we're still understanding the outbreak and ultimately where this goes. So we'll certainly continue to look at it. Thanks.
spk00: Great. Thank you. Appreciate your time.
spk06: Our next question comes from William Clyburn with Trutra. Please proceed with your question.
spk04: Yes. Hello. I had a question about, you know, your competitor, Bavarian Nordic, and, you know, what edge you guys might have over them. And please confirm if this is correct or not. I did a little bit of research. You guys are still awaiting FDA approval for the monkeypox vaccine while they are already FDA approved. I'm not sure when that occurred.
spk10: Sure. So thanks for the question. So Bavarian Nordic has a vaccine. It was approved, I believe, in 2019. That approval included monkeypox and smallpox. So that's a vaccine intended to be given pre-exposure to vaccinate someone and create immune response to protect against it. We're an antiviral drug. We were approved in 2018 for the treatment of smallpox. We actually did apply to the US FDA for a broader indication of smallpox, monkeypox, cowpox, and vaccinia. And at the end of the day, the negotiation was to only get the approval for smallpox. So we're an approved drug, but we are not currently approved for monkeypox. There are 1.7 million courses in the stockpile and drug is being used in this outbreak through the EAIND process that I mentioned. The one thing I'd also take the opportunity to mention is that the data that was used to get the approval in the US was also submitted to Europe. and the UK. In their reviews, they looked at that same data and gave us a monkeypox approval for treatment as well as smallpox. So that was done based on the animal data and then the human safety data. So thank you for your question. Thank you.
spk06: Our next question comes from Brian Adams with Carter Carey. Please proceed with your question.
spk01: Yes, hi. Thank you, and great quarter. A couple quick questions. As far as a pricing per dose, could you expand upon that? And from what I've read, it looks like it's $250 to $350 per dose. And the dose, of course, I believe is over a couple of weeks. But what does that look like from an international buyer? Would it be in that same price? Would there be a share structure with their international supplier? And then how quickly can you meet demand if you were to get a large order out of South America and or Europe? Thank you.
spk10: I appreciate that. So we don't talk about pricing specifically, but in the U.S. government contracts and the Canadian contracts, the pricing and the volume is disclosed. So I can, at a high level, say in the U.S., we sell between $300 and $400 a course, so that's enough to treat someone for 14 days. In Canada, that number is between $900 and $1,000. Basically, one of the factors, one, the U.S. government paid for development of our drugs, and they buy at high volume. They have a 1.7 million core stockpile in Canada. It was lower volume. And so our pricing is directly negotiated with government. It doesn't go through the traditional commercial sales channel. So that sale is directly to the government. We've commented in our filings around the margins associated with that, including the margin, including the fees that we pay to Meridian associated with international sales. So that is available in our filings.
spk01: Okay, thank you. And then also just to follow up as far as how quickly you can meet a large order out of Western Europe or South America.
spk10: Yeah, so it depends on how large is large. Certainly tens of thousands of courses, we have product available, we're ready to deliver. It will really depend on how large those orders come in as to whether we use current inventory, work in progress. or product that's moving along. But right now, with the orders that we have and anticipated, we believe we'll be able to deliver that out of inventory. Thank you.
spk06: Our next question is from Peter Ember with NorthPoint Partners. Please proceed with your question.
spk11: The first is, With respect to monkeypox, I've read a couple articles, I think one recent one from New England Journal of Medicine that cited some FDA comments that they want to do some additional testing with regard to monkeypox for TPOX to give a sort of a more formal approval. And they mentioned, you know, looking for adverse effects. And I was just wondering, In all the tests you've done so far, have there been significant adverse effects? If so, what have they been? Is there any sort of commentary you can provide around that?
spk10: Sure. So, Dennis, I'll defer to you to describe our clinical studies in support of licensure.
spk08: Yeah. Thus far, our experience in all of our clinical studies is that T-Box is a very safe drug. We've had no SAEs and very few AEs. The AEs we see are typically headache or diarrhea, but they typically occur about the same rate in the placebo. So we don't anticipate seeing any real side effect profile.
spk11: Thank you. That's helpful. And then my other question, slightly different path, but given the sort of different application to this, do you Do you anticipate selling this drug commercially versus, you know, typically it's been direct to governments?
spk10: Yeah, it's a great question, and certainly we're examining that and working on the ability to be able to launch it commercially. As you said, the drug historically has been sold to be stockpiled in the event of an outbreak like this, and right now in the U.S. that's how it's being deployed. But as the outbreak progresses, One scenario would be that it would become endemic. And just like COVID therapies that initially were bought by the US government, the expectation would be that ultimately they might go through a commercial, more traditional sales channel to accent patients. There's also hybrids of that that have been done over the years. Tamiflu was stockpiled by the US government for an influenza pandemic, but it was also sold in the commercial market. So we're doing the planning now and the analysis now as to what a commercial launch might look like for that. We think that that'll be important to have that efficacy data in humans for the full FDA and ultimately approvals around distribution. But that really will be driven by the virus and where it lands as the outbreak continues. Thank you very much.
spk06: Our next question comes from Todd Strunk with Strunk Investment. Please proceed with your question.
spk09: Hi, thank you all for the great job on the call. I wanted to ask you a couple of questions about one about the new jurisdictions that are becoming customers. How does that conversion look and what are the conversations been like, whether it be an initial order or a commitment to stockpile? Could you provide some visibility on that, please?
spk10: Sure. So I would say most all of the new jurisdiction discussions are around the current outbreak and trying to get product to those countries as fast as possible. So they tend to be, how do we get a relatively small amount here? How do we get a contract vehicle in place? How do we understand the regulatory import permits, supply chain and all that? So it tends to be an accelerated discussion compared to historic discussions around stockpiling. We do anticipate after that, There then is a phase where they start to think about what could this outbreak do long term? How do we get the right amount for monkeypox? And then we hope ultimately it will turn into that conversation around the broader stockpiling. We do have deliveries to individual countries. I will say we've been asked, and we ask countries if we can disclose. We are under confidentiality with those countries, with the exception of Canada. We've not gotten authorization to be able to say But what we have said is there were several countries in Europe. We've certainly announced countries in the Asia Pacific region as well. There are also ongoing conversations with pool procurement agencies. It's been reported the European Commission and HERA, which is the new organization in Europe that looks to do response, certainly has interest in Tika Viramat. The American Health Organization in South and Central America has also had reports that they're certainly interested in that. We have conversations with individual countries because sometimes they need it faster. We have conversations with multiple pool procurement agencies to see if there's a way to get better efficient access for regions that do pooled procurements.
spk09: Great, thank you. And just one other question and further to that is, you mentioned earlier that based on stockpile of what you've already got in warehouse, at what point do you need to look towards expanding or having secondary partners in order
spk10: to procure so is it that around a hundred thousand a million ten million um and what's some visibility around how you might partner and meet a massive demand if needed yeah so there's there's certainly many layers to that answer as i mentioned with our current partners and their current um kind of performance and scheduling of us we think we can get up to 500 000 courses a year we can get well north of that if there was a prioritization of those facilities um we also have support from barta to develop a second site of active pharmaceutical ingredient, which is one of the key components of that. We've been working on that development in parallel, so that would come online as time goes on. It's a little ways away, but that's another one that could be accelerated to bring that online. So the U.S.-based supply chain is robust and scalable. It really is a question of where ultimately the demand goes, but we're working through those scenarios. And the good news is our partners in the U.S. government have certainly thought about this with COVID. And so we look to them to be a good partner in this as we think about scale-up options. Beyond that, there could certainly be opportunities internationally. We've certainly had inbound calls and are thinking about what's the best way to scale even more broadly.
spk09: Great. Thank you. Keep up the great work.
spk06: Appreciate it. Our next question is from Chris Stario with Alistairi Investments. Please proceed with your question.
spk07: Hi, everyone. Thanks for the opportunity to ask questions here. So I guess if I was looking to build out a model that captures both international and U.S. TPOC sales, how should I be thinking about the price per course and what's a good ballpark number to think about here? And then is there any upside potential on that relative to sort of what you've sold at historically? I have a few others as well.
spk10: Yeah, so as I mentioned, we have disclosed that. I don't know, Dan, if you want to give an overview of that. And then I would say on the future, we look at any customer, as with the U.S. government, as a long-term partner, and we do think there's an important stockpiling component. So this is something that certainly in the long run we want to be consistent partners on pricing and availability and be able to deliver. But Dan, I don't know if you have any other comments you want to have, but we can refer to our financials, which have that information in there.
spk05: Right. So I would refer to the financials, and essentially what you would see through the financials in history is that for the U.S. government, for oil teapots, the low 300 range would be a number to use. And then for For IV, you can see that it's a slightly higher number, around the 400 range. Internationally, as Phil mentioned previously, the pricing has been higher than the U.S. because of a series of factors. In Canada, it was disclosed that it was between 900 and 1,000. I think you'd be safe to use that broadly. I will highlight, though, it is partly a function of, for each individual country, the size of the order. The bigger the order, the potential for numbers that could be different from that. And on the other side, the smaller, you know, really small numbers might be north of the $1,000. Okay, great.
spk07: Thank you. And I guess with the U.S. government's federal policy, emergency declaration, presumably that's going to free up some additional federal funding. And so when we think about potential access to that funding, how should we be thinking about that? Is that either potentially directly to the company or is it through BARDA? And then how should we think about, I guess, any expenses that the company may have to incur in order to ramp on production here with the CMOs that you're working with or any CapEx spend? Is there the opportunity to offset some of that cost with potential dollars that may come from the government and how should we be thinking about, I guess, margins going forward in the event that this outbreak sort of continues to accelerate and you have to meet a substantial amount of volume.
spk10: So I'll have Dan comment on the potential need for CapEx and the scalability of our model. But on your question around the emergency declaration, So that frees up some funding, but it's more details of the response within the U.S. government. I think the more important thing for thinking about opportunities beyond the procurement orders, we have about 300 million in remaining procurement orders with the U.S. government over the next few years. But if we think about them potentially ramping that up, accelerating them, or thinking about a different stockpile size, that will likely come through some sort of a supplemental appropriation. Historically, when there's a Outbreak, the Congress looks at the needs, the administration provides an update, and then that appropriation dollars is used for things like procuring drugs like ours. I believe the Biden administration has been reported, has talked about a number, you know, in a wide variety, including about a $7 billion appropriation. So that would probably be what would provide a material change to our contracting with the public health declaration, with the challenges we're seeing around the outbreak. We're certainly supportive of that supplemental appropriation, but that's where any material change in the plans would show up. But, Dan, do you want to talk about the scalability of the operating model?
spk05: Yes, it's very historically, and we believe going forward, very scalable. It's really a function of the fact that we outsource our supply chain, as Phil mentioned, the U.S.-based supply chain. So if you look at our financials, our CapEx really has been minimal given the outsourcing, and we anticipate going forward on the production side that CapEx would continue to be on the low side. Granted, we continue to look at it. With the monkeypox outbreak, there are so many different scenarios. We'll continue to look at it, but right now we don't foresee any big CapEx at the moment.
spk07: Okay, great. And last question for me. So I guess when you file, presuming that the data will be positive for the clinical trial for the approval in the U.S., what would you anticipate would be the timeline between when you would be able to get the data, then when you would be able to file for the supplemental label, and then when you would be potentially reviewed? I would imagine there may be some acceleration that could happen if you know, this outbreak continues to worsen?
spk10: Yeah, so I think the good news there is that NIAID, NIH, FIGA, the FDA, and the AIDS Clinical Trial Group, the ACTG, which is the clinical trials network, they'll be doing it, are all working together. So we anticipate, as data is generated, it will certainly be rapidly made available to both us and to the FDA. And it is, to your question, it is hard to predict because it could be based on the final data. If there was an acceleration of reviews under an EUA, whether it's before, middle, or after that clinical trial, it's hard to predict the timing. But we do anticipate if the outbreak continues the way its trajectory is going up, one, that will mean rapid enrollment of patients because of the large number of patients that can be enrolled. And two, the criticality of getting the final approval and more expanded access to the drug will also drive a rapid review. So it's really hard to predict right now, given all those variables. But as Dennis said, we do expect those trials to start quite soon, and we think we'll start to see data as we get into the fall, at least coming out of the initial parts of those studies. So it is progressing rapidly.
spk07: Okay, great. Thank you, everyone.
spk06: We've reached the end of the question and answer session. I'd now like to turn the call back over to Phil Gomez for closing comments.
spk10: So I'd really like to thank everybody for taking the time to join today's call. CIGA has been working on TPOCs for a large number of years and a great partnership with the U.S. government. I just wanted to end by thanking our partners over at BARDA and ASPR and NIH and the U.S. government for working to get us to this point. We've got a ways to go. We need to get access to the drug improved. We need to get these clinical trials done. but I think there is a great history here and a great partnership. The last thing I'd like to do is just thank all of my colleagues here at SIGA. People have been working around the clock, responding to a lot of requests and making sure that this drug gets out there, and it's with great pride that we deliver this drug, that we see some of the initial results that come out there, and we look forward to working with everybody to translate that impact on human health into value creation for our shareholders. So I appreciate your time today. Thank you so much.
spk06: Thank you all for joining the call today. If you have any additional questions, you can find CIGA's investor contact information at the bottom of today's press release. This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.
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