Greetings, and welcome to the SIGA Business Update call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements.

SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or 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, 2020, and its subsequent reports on Form 10-Q and Form 8-K.

I would now like to turn the call over to your host Dr. Phil Gomez, CEO of SIGA Technologies. Please go ahead sir..

Thank you for taking time to join today's call. Today, I'm joined by Dan Luckshire, our CFO; and Dr. Dennis Hruby, our CSO. We are pleased to have this opportunity to provide a quarterly update on our achievements and upcoming objectives.

On this call, I will provide a business update, Dennis will provide an R&D update and Dan will provide a financial update. We'll then be happy to take any questions. I'm pleased to report on an outstanding year for SIGA.

For the year ending December 31, 2020, we reported approximately $125 million in revenues as we began the resupply of the 1.7 million course TPOXX stockpile with the US government and as we made our first international delivery of Oral TPOXX.

In connection with the international product delivery, I'd like to highlight that over the last 12 months inclusive of the Public Health Agency of Canada contract awarded in early 2021, $47 million worth of international contracts have been issued for the future delivery of Oral TPOXX, $17 million of which relates to firm commitments and the remainder is subject to option exercise.

In light of SIGA's strong operating and financial performance, we were able to repay our term loan in full in March 2020, earlier than maturity and our Board of Directors authorized a $50 million share repurchase program, under which we repurchased approximately $28 million worth of shares in 2020, which amounted to more than 5% of shares outstanding as of when the share repurchase program started in early 2020.

Of course to state the obvious 2020 was not a year that anyone anticipated, given the COVID-19 pandemic. From a strictly business perspective, one key impact of the pandemic has been heightened uncertainty with respect to timing of certain procurement activities.

For the most part, we as a company have done a very good job of navigating the uncertainty. One area in which the direct or indirect impact of pandemic-related uncertainty has been magnified pertains to the timing of the international market build for Oral TPOXX.

As background government officials and departments across the world who we and our partner Meridian work with in terms of stockpiling conversations and decision making, are usually also the same people and departments, who are exquisitely focused on responding to the myriad of complications of the pandemic.

And sometimes health security government departments in response to these new challenges are being restructured to meet the near or long-term needs of pandemic response and preparedness. As such, we believe the results of the pandemic over time will be twofold, as it relates to our business.

In the near term, the pandemic will continue to subject SIGA to the risk of international business development activities coming to fruition slower than anticipated in some cases, something that we expect will continue in 2021.

Post pandemic, we believe that international governments will be better situated in terms of resources, experience and personnel to fully appreciate the importance of health security preparedness and the value that Oral TPOXX provides in that context.

As such, we believe this post-pandemic environment will have a net positive impact on our international business development success.

Importantly, I want to emphasize that the delay we've experienced with respect to an anticipated international order, as noted in our last investor call, does not change our long-term view of the international prospects for TPOXX.

With regard to the aforementioned anticipated order, we still expect the order to occur and conversations with the customer indicate that the order is on track albeit at a slower pace than planned.

As I have said on previous calls, international sales are complex and country specific, often with long lead times or with many parts of the government required to act in concert to purchase our product.

And although, one, we have seen some delays due to government staff rightfully focused on COVID-19 responses; and two, we have seen current government budgets across the world being dedicated to COVID-19 responses, we remain optimistic about the potential for additional sales this year.

That being said, we're also continuing to dedicate ample resources to our R&D efforts and have made significant progress on this front over the past year. We've advanced efforts to achieve regulatory approvals outside the US for the use of TPOXX for a variety of orthopox diseases and to treat during different stages of these disease life cycles.

We're also continuing to explore uses of TPOXX in several disease areas. And I will now pass the call to Dennis to run through these updates in more detail.

Dennis?.

Thank you, Phil. I'm pleased to have the opportunity to update our investors on the progress being made by the SIGA research and development team. As Phil mentioned, for Oral TPOXX, we continue to advance our efforts to achieve regulatory approvals outside the US.

Both the EMA MAA and the Canadian NDS applications, which were submitted last year have been validated by the respective agencies and are now undergoing full review.

We are responding to any comments or questions that arise in a timely manner in order to expedite the review process as much as possible and we hope to achieve those regulatory approvals in a late 2021 or early 2022.

As a reminder, both the MAA and NDS applications are requesting an indication for TPOXX for use against orthopoxviruses, which is a broader indication than the current FDA-approved label.

This is important as conversations with a broad range of countries as well as NGOs indicate that many government officials are thinking broadly about the best way to pursue health security and a therapy for a broad range of orthopoxviruses such as smallpox, Vaccinia, cowpox and monkeypox could resonate with this type of preparedness strategy.

We have seen monkeypox cases continue to be an issue in Central Africa, and cases outside of Africa in the U.K., Singapore, and Israel. It's important to note that, we continue to get requests from around the globe to use TPOXX to treat individuals infected with Vaccinia virus, cowpox, and monkeypox on a compassionate use basis.

We review those requests on a case-by-case basis. Separately, we are working on a collaboration that would allow us to reach a broader number of individuals who developed monkeypox in Central Africa and expect to announce that effort later this year.

On the FDA regulatory front, we continue to progress our efforts to achieve regulatory approval of Oral TPOXX for post exposure prophylaxis. As we have discussed previously, the strategy for this program has evolved as we have talked with the FDA to get feedback on our plans.

And I'm pleased to say, we believe we have an agreement on the path to ultimate approval. Together with our colleagues at the U.S. Department of Defense, final protocols for the remaining two clinical studies have been developed and shared, and obtained consensus with the FDA.

Having now received agreement from the FDA with respect to our protocols, we are working towards potentially launching both studies, concurrently as soon as the third quarter of this year, depending on a series of factors, including the general status of clinical trial availability in light of the COVID-19 pandemic.

As a quick reminder, the two human studies we are planning for PEP are. One, a study to evaluate whether there is any interference with the, Jynneos vaccine, and two, an expanded safety study. We anticipate these studies will be completed in 2022, with data to support the PEP indication.

We are confident based on the mechanism of action of TPOXX it will not interfere with the Jynneos vaccine.

Moreover, the outcome of these studies are not required for the purchase TPOXX doses for PEP, as we already have an FDA-approved product, and stockpiling may occur in advance of the label expansion if the government determines there's a need for it. With regard to IV TPOXX, the NDA is nearing completion.

And will be submitted to the FDA as soon as April. If all goes well, the U.S. FDA submission for IV TPOXX, should receive an approval in the early 2022 time frame. In addition to the PEP and IV programs for TPOXX, we also continue to progress our pediatric formulation, which is a powder for reconstitution.

Prototype formulations have been developed and tested for dissolution and solubility versus the Oral TPOXX capsules. We are selecting the formulation with the best properties and are preparing to initiate human clinical trials shortly, to evaluate and optimize pharmacokinetic performance.

We have shared our development plans for these products with the FDA. And they had no comments. Lastly, we continue to explore new avenues for the use of TPOXX, outside of orthopox diseases. We have collaborations with several companies in oncology that utilize Vaccinia virus in the product strategy.

Given the challenges of advancing products in this field, to late-stage development, this may still take time. We continue to be interested in the long-term potential of TPOXX to support these therapies, but recognize that most of the current investigational products are in early clinical testing.

And it will take time to determine, what if any market potential there is, for TPOXX in this regard. On TPOXX our efforts to develop a second small box antiviral ST-357 continue.

In collaboration with the National Institute of Health, we're conducting a medicinal chemistry campaign to improve the chemical attributes of the molecule to produce a lead candidate for advancement into development. We continue to seek additional outside funding to accelerate this effort.

Finally, let me close by thanking the SIGA staff, for their tireless efforts and tremendous contributions.

In these difficult and unprecedented times, they pivoted to working remotely and have continued to perform efficiently, effectively and cooperatively to advance the projects on-time, on-schedule, and simultaneously execute on our federal contracts and commitments.

A special thanks to the, SIGA IT team, for providing us with the tools to be successful. I'll now pass the call over to Dan, who will discuss our fourth quarter and full year financials.

Dan?.

Thanks, Dennis. For the three and 12 months ended December 31, 2020 SIGA's revenue was approximately $38 million and $125 million, respectively. For the quarter approximately 112,000 courses of oral TPOXX were delivered to the SNS, generating revenue of approximately $35 million.

For the year approximately 363,000 courses of oral TPOXX were delivered to the SNS resulting in the recognition of approximately $113 million of revenue. Revenue for the year also includes approximately $2 million of revenue in connection with the delivery of oral TPOXX to Canada reflecting consummation of our first international sale.

Operating income which excludes costs in connection with the term loan retirement, interest expense, interest income, taxes and adjustments to the fair value of the warrant was approximately $27 million and $85 million, respectively for the three and 12 months ended December 31, 2020.

Net income for the three and 12-month period was approximately $20 million and $56 million, respectively. In turn, fully diluted EPS was $0.26 per share for the quarter and $0.71 per share for the year. At December 31, the cash balance for the company was approximately $118 million.

During the fourth quarter, SIGA repurchased approximately one million shares of its common stock for approximately $6.7 million.

For the full year 2020, the company has cumulatively repurchased approximately 4.6 million shares of its common stock for approximately $28.5 million, which as Bill mentioned is more than 5% of outstanding shares of the company as of the beginning of the year.

Looking beyond the 2020 financial results, it remains up to $459 million of TPOXX procurement revenues tied to existing contracts. Most of which is currently expected to be earned over the next four years. These revenues would come from the 19C BARDA contract and the Canadian contracts.

The 19C BARDA contract is up to $414 million of procurement-related options remaining for future exercise by BARDA. And there is up to $45 million of revenues tied to the Canadian contracts for oral TPOXX.

With regard to the $45 million of revenues related to Canada, $33 million of the revenues are tied to the recently announced contract issued by the Public Health Agency of Canada -- PHAC with the remaining revenues tied to the contract with the Canadian military.

The PHAC contract specifies firm commitments for the purchase of approximately $17 million of oral TPOXX by March 31, 2023. The remaining courses under the PHAC contract are scheduled to be purchased after March 31, 2023 and are subject to options exercised by PHAC.

We expect to deliver approximately $10 million of oral TPOXX to PHAC in 2021 with initial delivery and acceptance in March of approximately $3 million of oral TPOXX. As a quick reminder, the Canadian contracts were both awarded to Meridian Medical Technologies under the international promotion agreement that was entered into by the parties in 2019.

This concludes the financial section of the call. At this point, I will pass it back to Phil for a brief summary. .

Thanks, Dan. I want to underscore that we strongly believe that our achievements in 2020 with respect to TPOXX in combination with the additional formulation, label expansion and geographic expansion goals we are pursuing provide a bright future for SIGA.

We have a combined $459 million of TPOXX procurement revenues tied to existing contracts that we anticipate will be mostly recognized over the next four years. We anticipate building on this base with additional international sales.

Also we believe the PEP program supports consideration of a larger SNS stockpile, which in turn would result in larger US government procurement contracts. While revenue from the government contracts can be lumpy, we believe that the earnings power of the TPOXX business is substantial as evidenced by the 2020 financial results.

It will not be without challenges however. As I've discussed previously our current contract for procurement of oral TPOXX is with BARDA and we are now post FDA approval.

This means we will ultimately be transitioning to a contract with a strategic national stockpile and we're working with the US government on option exercises under the BARDA contract and long-term procurement planning. It is however challenging to do this during the start of a new administration and in a COVID-19 pandemic.

We are focused on ensuring the stockpile is maintained at 1.7 million courses and our manufacturing product for delivery this year. Given these realities, I expect deliveries to begin in the second half of 2021.

As earnings generate cash, we will continue to examine the best use of our cash including continuing share buyback and as well as potential investments or acquisitions that provide an opportunity to grow earnings and leverage our successful platform. Before I close out with some goals for 2021, I'd like to share a brief corporate update.

I would like to welcome Edison Group as our new Investor Relations advisory firm. Edison Group is a global Investor Relations firm that has unique expertise and global reach, which we believe can help SIGA continue to broaden its footprint worldwide and enhance its visibility with key audiences. We look forward to working with Edison.

In summary, we will continue to pursue a full range of avenues in 2021 and beyond to create value including continued delivery of oral TPOXX courses under the 19C BARDA contract pursuit of US stockpile expansion to cover PEP, pursuit of additional international sales through Meridian and international regulatory approvals to support those sales seek approval for label expansions for TPOXX to include PEP and other orthopoxviruses; expand and support ongoing oncology collaborations for TPOXX and leverage our capabilities for new formulations and potential new products.

This concludes our prepared remarks and we will now begin the Q&A session. .

Thank you. [Operator Instructions] Our first question comes from Max Jacobs with Edison Group. Please proceed with your question..

Hi, guys. Thanks for taking my call. I just wanted to know -- just a couple of quick questions.

I want to confirm that there are no additional animal requirements for the PEP study?.

This is Dennis. That is correct. We've had the conversation with the FDA and they've confirmed there are no additional animal studies required. .

Okay great.

And then just another quick question, which is just in terms of the stock repurchase program, I mean did you do any repurchasing during the first quarter of 2021?.

Dan, I'll hand that to you. .

Sure. We have continued that program in 2021. We're not going to share any details, but consistent with what we've been doing in 2020 we have continued into 2021. .

Okay, great. Thanks for taking my questions..

Thanks Max..

Thank you. [Operator Instructions] Our next question comes from Joaquin Horton [ph], a private investor. Please proceed with your question..

Hi, Phil..

Hey, Joaquin..

I'd like to ask you the question is can you give us any guidance as to what your first quarter will look like sales-wise? My recollection is we have quite a bit of product being delivered to Canada this quarter. And probably some continued R&D revenues..

So, Joaquin thanks so much for that question. On the R&D expenses and reimbursements, we obviously have continuing work there, and we will have reimbursements. Dan did describe one delivery that we recently planned to do here in March. On that, we're not giving overall quarterly guidance on revenue.

But Dan, if you want to reiterate the delivery that you did highlight in the script?.

Certainly. So, for the year, we expect to deliver $10 million worth of product to Canada. Of that $10 million, we expect to deliver $3 million of product to Canada in the first quarter..

Okay. So, it was my understanding for the military contract we were supposed to deliver significantly more in the first quarter of this year.

Am I wrong with that?.

Dan, I hand it over..

Yes. Sure. Yes. So, yes, I believe the military contract specified that we made our initial delivery, and then they were looking toward our regulatory approval within Canada before resuming deliveries..

So, in other words, you had to wait for the approval in Canada first?.

That's how they're set up right now. They reserve the right to adjust, but at least, as of the time of the issuance, they were looking towards approval before receiving additional deliveries..

Okay. Now this next question has something to do with -- we've all watched the government in action here with the COVID. And I think they performed fairly well getting the vaccine out.

How do you think that they would perform with such a small stockpile if something should happen in a way of smallpox? I mean are they just planning to cover Washington DC or what about the rest of the country?.

And so, Joaquin, I agree with you on that. I think COVID and an outbreak of a virus that we've talked about previously is not as infectious and not as deadly. Having simply 1.7 million courses, does not seem like a reasonable amount to be able to cover in what would be such a deadly outbreak.

And as you know, we've echoed that given the fact that it would -- our drug would be used ultimately in a prophylactic way, and that's why we're pursuing approval of it. So we certainly agree with you on that. The government has many threats that they assess and we continue to talk with them on it, but I think it's an excellent point that you make. .

Thank you. Okay. The next point is being out here, just the public, and we've got an improved product to sell to the government. What does it take to have an approved product to sell to the public in case we can't depend on the government to provide us with some TPOXX..

Yes. So that's -- I appreciate that question. Joaquin, as we've sent our filings, our label is for the strategic national stockpile only currently. It requires a couple of things.

We have a very lean supply chain that had some additional items that a normal commercial supply chain would have, that we didn't have to do as we went through FDA approval, namely serialization which is putting unique numbers on each of the containers, so we would have to do that.

And we'd have to work with FDA to get a label on the product that would allow for broader prescriptions of it. I think our strategy in Europe of going more broadly, being able to not only look at smallpox but monkeypox, cowpox, cowpox has cases, monkeypox has cases, allows us to have that broader conversation.

And certainly our plan is to ultimately loop back with the U.S. FDA, as we go through our regulatory strategy. And I do agree with you. It is something that we do want to do. We think it is helpful.

And I think the last year in COVID has really highlighted that it's important for people to have access to things, because you can't always depend on the government for everything.

So I think that would be a more robust health security strategy for us as a nation to have not only the government, but the private sector et cetera, able to access countermeasures and be able to ensure they have access to them. So I appreciate your questions. Thank you so much..

Thank you..

Thanks, Joaquin..

Thank you. Our next question comes from Matthew Mark with Jet Capital. Please proceed with your question..

Phil, I apologize if I missed this on the call, in your opening, but can you review what the prospects are for international orders in the coming quarters outside of the performance in Canada?.

Yes. So we -- what we highlighted was, as we talked about last year, we had another order that we were anticipating coming from other country, that was delayed based on our initial estimate last year. The feedback from the customer was that was due to their resource focus on COVID-19.

So we continue to have conversations, I would say, Matthew, with multiple countries. It is especially difficult to predict right now, because we need to have both access to those people, which we have to do remotely, and we need a variety of folks in each of those countries to all agree and allocate dollars for purchase.

So the guidance that we're giving is, we are confident, we will have additional orders this year. But we do have to monitor it closely and we certainly have had delays like the one I described from last year.

So the nice thing that I think we saw last year was we were extremely impressed with Canada, both our military and civilian organizations worked in parallel with COVID to execute on meaningful stockpiling of TPOXX and we'll certainly continue to work with our colleagues at Meridian to make it as easy as possible for us to be able to bid on and provide product to customers internationally.

And then the last part, as Dennis mentioned we are getting our Health Canada approval late this year early next year and our EMA review late this year early next year. Not all countries require approval before sale, for example Canada has taken deliveries before approval. But there are some countries especially in Europe that would like to see that.

So we think that's also an important step we're taking this year as we advance those sales. .

Thank you. Second question the federal government as you know is in the middle of a very large expansion of its budget and very large investment in preparedness. In addition the administration and Congress are working on a further expansion of the budget and investment in infrastructure among other items later this year.

Is it a realistic prospect to think that any of that activity will lead to an expansion of the stockpile in 2021 in the US?.

So yes, I think you highlight one of the key factors around the ability of the U.S. government to expand the stockpile which is budget because they do have many products they want to buy and they've certainly articulated they need more budget to do that.

So we do think this is a critical year both because there have been draft legislation for example for the most recent COVID relief package that allows the procurement of countermeasures for COVID-19 and other pathogens that might cause pandemic. So we'll have to wait and see what gets passed.

But there seems to be a growing recognition that COVID is what's here now. But we do have to prepare more broadly. And there's also what we think of what preparedness means in health security. So I would agree that there is some optimism about the budgetary potential to increase which does help us and others in this field to do it.

The other requirement is for the government to make that policy decision and look at the stockpile size and actually have the group that makes those decisions get together and agree to buy them to -- government. So it's a diverse group of people.

We continue to have conversations with them, educate them, provide analyses et cetera to make sure they understand the implication and we'll work very hard on that. I know this is not a pleasant answer as with international. It's a government and it's hard to predict exactly when they're going to act on things.

So we continue to educate them and we'll have to see how their process develops. It is something that would be hard to see in months not years but we'll continue to push on it. And I do think we have a window here with COVID to certainly get people to understand the broader implications of not only health, but economic impact which is so critical.

And as Joaquin pointed out and I certainly agree there's just not enough in the stockpile that would really be needed if there is an outbreak. So thank you. .

Thanks..

There are no further questions at this time. Ladies and gentlemen this concludes today's web conference. You may now disconnect your lines at this time. Thank you for your participation and have a great day..