Q2 2022 SIGA Technologies Inc Earnings Call
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to update publicly any forward look and 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 10K for the year ended December 13th, 2021. I'm 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.
Thank you for taking the time to join today's call. Today I'm joined by Dan Luxhire, RCFO, and Dr. Dennis Ruby, RCFO.
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 T-POCS 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 T-Pox 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 teapots, in addition to the large number of continuing inquiries regarding teapots usage for monkeypox and 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 and viruses such as the orthopox virus family. And secondly, the T-Pox is a significant component to any robust public health program designated to protect against orthopox virus 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 Monkey Pots outbreak as a public health emergency of international concern reinforces the serious nature of the outbreak and its potential. The
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. The number of deaths in the monkeypox has now been re-explanated and passed on to the number of deaths in the monkeypox. And there are anecdotal reports in the monkeypox. The number of deaths in the monkeypox. And there are anecdotal reports
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 we expect with regard to the ultimate scale and scope of the Monkeybox 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, quarantine that require three weeks or more have a significant impact on patients who cannot work or interact with family members. families through the uh...
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 the outbreak.
Supply challenges, vaccine hesitancy, and ongoing cases require both vaccination and treatment to address the impact.
Fair.
The outbreak has highlighted the importance of stockpiling of teapots to mitigate the impact of worth of pucks virus outbreak. The outbreak has highlighted the importance of stockpiling of teapots to mitigate the impact
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 some, 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 resize 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. Rice
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 teapots.
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 T-pox for monkeypox patients. The T-pox for monkeypox patients.
As background, the FDA has indicated that it wants efficacy data and the treatment of monkeypox for full approval of keypox in the U.S. for the monkeypox indication. The FDA has indicated that it wants efficacy data and 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 T-Pox was approved by the FDA in May. And oral T-Pox 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 T-Pox in the approximate span of little more than half a year. The other regulatory approvals being the oral T-Pox approval by the European Medicine Agency, EMA in January , and Health Canada approval in December 2021.good.
I will note that the EMA and MHRA approvals include broad labeling for oral T-POPs, indicating its use for the treatment of monkeypox, smallpox, cowpox, and vaccinia complications, and vaccination against smallpox. The EMA and MHRA are the most common in the world. The EMA is the most common in the world. It is, including, that the EMA was,
All of these regulatory approvals were based on animal efficacy data. With human clinical trials conducted to demonstrate safety and pharmacokidetics consistent with the levels that protected non-human primate.
Those studies, published by Dennis in the New England Journal of Medicine in 2018, showed over 90% protection from death in the lethal challenge model.
During an outbreak, whether smallpox or monkeypox, we always anticipated collecting confirmatory efficacy data in humans. The ?? Kor gigaishi Kor giga Hon registered The Morning cake Honunde Kor giga Hon? Hon? Hon? Hon? Hon? Hon ? Hon Cour Hon Ar Ar Ar A Ko through In my Dr. O. Sunday Moray Parch wonders tattoos on black Hermit Miac Ar 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 TPOCs in outpatient settings.
The data and nonhuman primate show the treatment with T-POP stop progression of the disease and reduced viral shedding. We believe these studies will provide a basis for approval in the US for monkeypox and support for water use of T-POPs to treat a broader set of patients representing 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 world 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 or revenue-based. As a reminder, our revenue-based expanded in the first quarter when we made our first delivery of the intravenous T-POTS of 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?
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 T-box 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 keypox for post-exposure from Lexus.
For the expanded safety study, we have set up nine clinical sites around the US. And these sites began dosing mid-quarter. Our characterized enrollment is being up to 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 T-Pox Plus Genios Immunity's 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 monkey box outbreak gained a substantial threshold in the US, enrollment has begun to improve. With the monkey box 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 showed the expected results, we would commence assembly activities for a package requesting regulatory approval of key box.
Shifting gears I'd like to now discuss clinical activity in connection with all T-Pox and monkey parks.
We are currently supporting and insisting with launching up to 10 clinical trials in Africa, Europe , and North America. The formulae assess the effectiveness of T-Box to treat and or prevent monkeypox and human patients. The formulae assesses the effectiveness of T-Box in frequency of Wall Street Journalism. that human patience.
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 monkey box indication here in the US to facilitate getting drug to those who need it. Here in the US 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 T-Pox 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 T-Pox whenever possible.
With that update, I'll turn the call over to Dan.
Thanks, Dennis.
For the three and six months on June 30th, 2022, biggest revenue is approximately $17 million and $27 million respectively.
for the second quarter, approximately $5 million of revenue relates to international sales of oral cheap-hocs.
Approximately $4 million relates to sales of World T-Pox to the US Department of Defense and the remainder relates to resuscitation development activity.
In connection with the sales of oil cheap hocks, the 5th cases were first time sales to a new customer. The 5th cases were first time sales to a new customer.
For the six months and a June 30th, approximately $79.00 of revenue relates to sales of the U.S. government.
Approximately 9 million dollars 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.
is approximately $3.1 million for the three months and June 30th 2022.
For the six months in the June 30th, operating income was approximately $1.6 million.
That income for the three months and a June 30th, 2022, was approximately two million dollars.
For the six months ended June 30th, debt income was approximately $1.7 million.
In turn, fully deleted income per share for the three months and a June 30th, 2022 was free cents per share. And for the six months and a June 30th, deleted income per share was two cents.
At June 30th, 2022.
The cash balance for the company was approximately $115 million.
During the second quarter, she could declared in pay the special cash dividend for 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.
Be expect to use cash to proactively build, work in process inventory.
We're active from a surgical ingredient.
With respect to the $60 million of international orders received this year, as of July 31st.
Approximately $5 million of these awarders were delivered in the second quarter 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.
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 and connection with the treatment of monkeypox. It is our understanding that Tpox is deleting and likely the only in many countries therapeutic that is being used or expected to be used.
in the US, 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 T-Pox, to monkey box patients, and to pursue appropriate stockpile.
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 US, that have ordered TPOCs and we continue to work hard to expand that base.
Well, 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. This is gradually taking shape. This 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 stock pilot expansion. As stated on earlier calls, we believe the current size of the stock pilot of T-Pox would not be sufficient to treat all those who would eat care in many outbreak scenarios.
A lesson from the COVID pandemic, which is being reinforced by the monkey-poss 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 SNS contract that focuses on appropriate size requirements for the T-Pux stock file as well as smoothing 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.
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Our first question comes from Sue Romanov with Edison Group. Please proceed with your question.
Are you there, Sue?
Are you muted?
Yes, sorry about that. That's okay. Please proceed with your question.
Great, thank you. You know that the most interesting thing is your model is pretty...
The ability to predict your revenues is pretty easy in the US, mainly because of those stockpiles. Did you give us some guidance on...
and facilitated penetration rates or, or if there are any supply chain.
Restrictions against state.
All right, so thanks so much for your question. As you highlight in the US, there is a 1.7 million course stock file. We have discussed and pointed out that that would like to be inadequate in the case of the smallpox outbreak. And our post-exposure program is looking to add that label to increase the availability of that stockpile in 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 monkey pox as a serious threat even when the first cases came. There was a lot of statements around limited morbidity, limited mortality, and a bit of a wait and see approach, which was unfortunate. For those who were being Fine I think just think that,
Government 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 US 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. 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 US, 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 US-based supply chain that has been delivering product to the US Strategic Dontional Stock Pile 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 US 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, sir.
Yeah, one more question. You know, where are we? I think with the US approval here for monkeypox, it seems like you're getting some positive news directionally, but I was curious if we had any idea signing on that. But I was curious if we had any idea signing on that.
Just to clarify, so I think we're probably asking about efficacy data in patients. Maybe I'll hand it over to Dennis, it's early innings, but Dennis, do you have any comment
Yeah, the FDA has consistently asked for controlled clinical trials to demonstrate efficacy and safety before they would grant a monkey box 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 US in the clinical trials network. There's one in the UK and there's one in Canada. All these are using...
essentially the same protocols while the same endpoints and that data should be coming out over the matter the next few months. So that data accumulates I think will mean a position to apply for approval for multi-boxer in the US.
and then we will pin it this up.
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 I&D. We've certainly been very supportive in trying to respond to any data request from FDA to help understand ongoing clinical studies. What?
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-dating 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 of the day and the work FDA CDC doing, we're encouraged that we'll continue to make progress on that front at FDA and CDC. Thanks.
Our next question comes from Ben Raboseh with Story Trading. Please proceed with your question. Please proceed with your question.
Hi, I got caught off at the beginning of QI, Q&A, so I don't know if he covered this, but can you give me an idea of the opportunity, I guess next six to 12 months for smallpox sales, versus monkeypox sales, I noticed you know on Q4, you did over 100 million with that contract, with the federal government, so where's the bigger opportunity for you?
Yes, 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 hundred and twelve point five million dollar orders We anticipate that would come in 2020 and 24
So in 2021 and 2022, we had two orders that would be delivered. As we've said on previous calls, you not anticipate a high number of expiry this year. So we anticipate next year in the year after we would have the similar delivery on the smallpox front for the US government. Obviously the monkeypox out in the use of the drug could imp that. We think it's important to forward manufacture and get those deliveries in as soon as possible, but that is the monthly up to these government. Your question on monkeypox, the silent one, we're monitoring up right closely.
I would say a couple things and then maybe hand it to Dennis as we think of. What I read is that it is around scenario planning and thinking how many people to use using the drug. The studies are being designed now that are post-entralled, we'll focus on outtons, so people who get that, I'll go through, we'll get treated, not just the severity phase of the disease. So we're gonna move away, but I think we think this virus unfortunately might be here to stay in becoming in some regions.
But what we can't say and what we're monitoring closely is ultimately what the market offers to be and if it would be larger or smaller than the caramel pox market. But this is a fan of viruses. And so what is important to remember is whether it's monkeypox, whether it's the central collate of monkeypox that has been shown to be up to 10-10 fatal, whether it's hox, whatever it might be, these types of antiviral drugs are critical to have available. Then it will help you add anything in on your personal nyoploid.
No, I agree and most experts agree that monkey pot is safe. I think we're underestimating how much disease burden there is because of the diagnostics and prolonged incubation period of this. We're also starting to see it spread from the current MFM population in Bilgarn and others. We're starting to see some deaths. I think this is going to go away and it's going to be a significant problem for a significant period of time. I think it's going to be a significant problem for a significant period of time.
Great, just wanted to make sure to you correctly say, in not this year, but you're in 2023, you'd expect a similar size or from the government, we're talking about like a hundred million or so. We're talking about like a hundred million or so. We're talking about like a hundred million or so.
That is correct. In 2023 and 2024, there are two essentially options or orders remaining on our existing track that we will be executed in 2023 and 2024, each of those out of $5 million.
Okay, great. Last question. I wanted to know what you're thinking around the short repurchases. Stocks is up quite up. So going forward at these levels, can we expect that to continue for how do you think about all of the company?
I would say that we have I'd like to say that we have a 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-sell 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 has a lot of scenarios as to where it goes. We've been disciplined in the past to make sure we have clarity, where we're going.
from a cash basis so we will continue to look at share repurchase, continue to look at dividend, continue to look at the best of cash. Certainly right now we're still ending the outbreak in Ultimally Let's Go. So we'll certainly continue to look at it. Thanks. Great, thanks. Take your time.
The next question comes from William Clyburn, which please proceed with your question.
Hello, I had a question about your competitive but anortic and you know what ed you guys them and please confirm if this is correct I did a little bit reach you guys are still FDA approved for a monkey pox for the monkey pox vaccine they are already FDA approved. I'm not sure when that occurred.
Sure, so thanks for the question. So the very Nordic has a vaccine. It would have been believed in 2019 that approval included Monty Pox and Spock. So that's a vaccine intended to be the exposure to vaccinate someone in creative minerals and protect against it. Were an antiviral drug approved in 2018 for the treatment allpox. We actually did apply to the USFB a broader indication of smallpox, Monty Pox, catpox, Xenia.
And at the end of the day, the negotiating was to only get the approval for smallpox. So we're an approved drug, but we are not currently approved for monkeypox. Our 1.7 million course stockpile and drug is being used through the EAA process of that intention. The ones to take the opportunity to mention is that the data that was used to the approval in the US was added to Europe in their use. They looked at that same data and gave us a monkeypox treatment as well as smallpox. So that was done based on the animal data and then the human safety data. Thank you for your question.
uh... and of course i believe is but what does that look like to buy or what if you have in that same price would be with their share with um...
you know, with their international flyer? And then quickly, can you meet the man in a large order out of South America and or Europe ?
And then quickly, can you meet the man where they get a large order out of South America and or Europe ? Thank you.
They appreciate that. We don't talk pricing specifically, but in the government contract and the Canadian contract, the pricing and the volume's low. So in a high will say in the US, we fell between $300 or $400 a course. So that's enough to treat someone for 14 days in Canada that number was between 900 and 1000. And that's basically factors one that's government paid for development of our drugs and they buy high volume. They have a 1.7 million course stock of high will in Canada was lower volume. And so our pricing.
So it depends on how large is large. Certainly thousands of courses we have product available. We're ready to deliver. It will really depend on how large orders come in as we use current inventory, progress, product that's moving along. But now with the orders that we have and anticipated we believe we'll be able to deliver that out of the way.
is large. Certainly thousands of courses. We have product available. We're ready to deliver. It will really depend on how large orders come in as we use turn inventory, progress, product that's moving along. But now with the orders that we have and anticipated, we believe we'll be able to deliver that out of the board. Thank you.
Our next question is from Peter Ember with Northpointe Parts. Please proceed with your question.
The first is, with respect to monkeypox, I've read a couple articles, I think one recent one from the New England Journal of Medicine that cited some comments that they want to do some additional thing with regard to monkeypox, for its pox to give a sort of a formal approval. And they mentioned, you know, looking for adverse effects. And I'm just wondering, in all the tests you've done so far, is there, you know, have there been significant...
real side effect profile.
Thank you. That's helpful. And then my other question, slightly different path, but.
given the sort of different application to this, do you anticipate selling this drug commercially versus typically it's been directed to governments?
Yeah, it's a great question and certainly we're examining that and working on the ability to launch it commercially. As you said, the drug historically has been sold to be filed in the event of an outbreak and right now in the US that's how it's being deployed. As the outbreak progresses, one scenario would be that it would be endemic and just like COVID therapies that initially were bought by the US government, the expectation would be...
that they might go through a more traditional sales channel to extend patients. There's also a hub that have been done over the years. Tamiflu was stock filed by the US for an influenza pandemic. It was also sold commercial market. So we're doing the planning now. And the instance now is to what a commercial launch might look like for that. We think that that'll be important to have that efficacy to end humans for the full FDA, assembly approvals distribution. But that really will be driven by the virus and where it lends us the outbreak.
through a more traditional sales channel to extendations. There's also a lot that have been done over the years. Tamiflu was stock filed by the US for an influenza pandemic. It was also sold commercial market. So we're doing the planning now. And the instance now is 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, ultimately approvals distribution. But that really will be driven by the virus and where it lends us the outbreak. And thank you very much.
Our next question comes from Todd Strongk with Strong Conventment. I hope you will receive a few questions.
Hi, all for the great job on the call. I wanted to ask you a couple of questions. One about the new jurisdictions that becoming cost. How does that look? And what are the conversations that might be in an in-order or a commitment to stockpile? Could you provide some visibility on that place?
So I would say most all the new jurisdiction descends are around the current outbreak and trying to get product to those countries as possible. So they'd be, how do we, relative small amount here, we get a contract vehicle, how do we understand the regulatory import permits, the chain and all that. So it tend to an excelled discussion, compared to historic discussions, docpiling. We've just paid after that. There's then a phase where to think about what could this outbreak?
long-term and we get a big amount for monkey parks and ultimately it will that conversation around the broader stockpiling. We do talk, we do have deliveries to the entries. I would have been asked and we ask if we can disclose, we are confidentiality with those countries with the exception of Canada, not in that authorization to say the GRG. Well, what we have said is there were countries in Europe , certainly announced countries in the Asia Pacific region as well. There are ongoing discussions with pool procurements, the EU has been reported, the European...