Good day, ladies and gentlemen, and welcome to the SIGA Technologies Quarterly Business Update Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Mr. Todd Fromer, Managing Partner of KCSA Strategic Communications. Sir, you may begin.

Thank you, Mary, and thank you all for joining us today. This is Todd Fromer, Managing Partner of KCSA Strategic Communications, Investor Relations Consultant to SIGA Technologies. Hosting the call today are Dr. Eric Rose, Chief Executive Officer and Chairman; Daniel Luckshire, the Chief Financial Officer. Today's call is being simultaneously webcast and is available on SIGA's website. A replay of the call will also be available in reported format and on the company's website. Before we begin today, I would like to remind everyone that this conference call contains statements that constitute forward-looking statements. A Safe Harbor statement covering this call will be read at the end of the call and can be found in our press release for financial results for the fourth quarter and year ended December 31, 2012. With that said, I'd like to turn the call over to Dr. Eric Rose. Eric, the floor is yours.

Thank you, Todd. Good afternoon, and thank you all for joining us for our business update call. During this call, we will provide you with a business update, and then we'll open the line for questions. It has been quite a fruitful period of time since the last investor call. In November, we branded our smallpox antiviral treatment as Arestvyr. Also known as ST-246, our smallpox antiviral treatment is becoming increasingly better known around the world, and adopting the Arestvyr name represents another step in our commercial stage transformation. In December, we entered into a loan agreement with GE Capital, which expanded our capital base with additional non-dilutive funding. In January, oral arguments relating to the PharmAthene litigation were heard by the Delaware Supreme Court en banc. Based on the court's historical response rate, we believe that a ruling by the Supreme Court is likely to occur in the near term, either this month or in April. Now it's March. And this month, we expect that approximately 190,000 courses of Arestvyr will be accepted by BARDA into the Strategic National Stockpile. The acceptance of approximately 190,000 courses into the SNS will be an important achievement for SIGA. It will confirm our company's capability to successfully execute on long-range strategies and is expected to lead to significant cash inflows in 2013 and beyond. We're looking forward to building on this momentum. On the regulatory front, we have begun to carry out specific development activities based on regulatory guidance from the FDA. Development activities we are performing build on -- upon recommendations from the FDA Advisory Committee, which was held in December 2011, and are expected to involve a series of animal studies and human safety studies. We expect that the incremental animal studies will serve as confirmation of efficacy results achieved in our previously performed nonhuman primate test. As of December 13 -- 31, 2012, SIGA had $54 million of available funding from BARDA that is expected to be mostly used for development activities related to our drug. We expect that these development activities will have a timeline that probably extends beyond our product delivery schedule, which we expect to achieve over the next 2 years. At this point, I'd like to hand the call over to Dan.

Thank you, Eric. Good afternoon to those on the call. I'd like to start with further discussion on our product delivery expectations for the next 6 months and thereafter. As Eric mentioned, we expect that approximately 190,000 courses of Arestvyr will be accepted into the Strategic National Stockpile in March. This is a substantial step toward the cumulative 500,000 course delivery threshold, which we must meet in older to invoice and receive payment for delivered product. We expect to surpass the 500,000 course delivery threshold within the next 6 months. Additionally, we expect to fully deliver 2 million courses of Arestvyr within the next 2 years. Please note that revenue recognition for cash receipts related to product delivery has been deferred up to this point, and it is expected that revenue will continue to be deferred after we surpass the 500,000 course threshold. Revenue on these items is expected to be deferred until we satisfy all obligations related to the delivery of courses. Cash receipts from the delivery of products, when they occur in the future, are expected to materially enhance our cash resources. At December 31, 2012, our cash, cash equivalents and short-term investments were $32 million. This amount includes $4.9 million from the issuance of debt in December. This concludes our prepared remarks. Thank you for attending this business update. We will now open the line for questions.

[Operator Instructions] Our first question comes from Adnan Butt from RBC Capital Markets.

I'll ask it, hopefully you can address something about this. But naturally, it's about the litigation process. Can you discuss what the potential outcomes could be? And what would be the steps beyond those outcomes?

It's not something that we speculate on, and I really can't comment beyond that.

Okay. Then let me try a second question, and then I'll get back in line. You mentioned something about 246 getting better known around the world. Is there any interest from outside the U.S. in terms of the -- stockpiling the drug at this stage? Or do you feel that it's something that would require approval before something can materialize at that -- on that front?

I think there is -- this is Eric Rose. I think there is considerable awareness of our drug, of its potential use in biodefense, and certainly, the acquisition of the drug into the United States SNS is something that is drawing attention from other countries. There is no analogous legal framework in other countries to the emergency use authorization type of mechanism that's the basis for the BARDA acquisitions of drugs like ours, and I'd say also like most of the other drugs that BARDA's acquired, which have later gone on, typically, to full approval. I think there is considerable interest on the part of policy people in these other countries that we've discussed this with to explore potential mechanisms that would allow them to acquire drugs earlier, at an earlier stage than FDA approval. Beyond that, I don't think we can say anything more as to whether or not such countries might acquire our drug prior to regulatory approvals.

If I can just ask one question about the ruling that might occur in March, April. Do you expect to press release that hearing, that ruling? And then would you consider holding a conference call based upon the ruling?

Can you repeat the question again, Adnan?

Would you be press releasing the results of the ruling that's expected?

Oh, I think it's fair to say that the ruling will be material to us. And of course, we'll meet our regulatory obligations and our obligations to shareholders, of course, to discuss it.

Okay. I'll get back...

We expect the ruling to -- when it's available, it will be publicly available immediately. That's the nature of the releases, as I understand it, from the Delaware court system.

Our next question comes from Greg Wade from Wedbush.

Dan, with respect to revenue recognition, did I hear you correctly when you said that you won't be able to recognize any of the revenue until all obligations are met? In that, does that include FDA approval?

Yes. That -- we have -- we've been deferring revenue to this point. And yes, we'll be continuing to defer revenue until we meet all those obligations. And correct, there's multiple elements to the contract, one of which is FDA approval. So you are correct in that, that is part of the elements that had to be satisfied before revenue recognition. All these elements are -- when you go through the accounting of this contract, are linked together. And so yes, revenue will be deferred until that obligation is fulfilled.

How should we think about taxes?

Well, taxes are separate versus GAAP. We will be in a position of using NOLs. It will be taxable income as we receive cash related to deliveries, but we do have a significant NOL to apply against net income.

A couple more questions. With respect to the supply chain for Arestvyr, are you producing sort of on a continuous basis about 190,000 courses a month?

We have now a validated production process, and that's now morphing into a commercial production process. And we expect over 20 -- the next 2 years, 24 months, to produce approximately 2 million courses. So I guess the math for that would come out to a little bit less than 190,000 courses per month. But it's in that 100,000 to 200,000 course per month ballpark.

Yes, I think, to summarize what Eric said is that there's flexibility in the supply chain to move up and down in terms of capacity. Right now, it's not 190,000 per month. It's -- there's a lumpiness to it still, so 190,000 per month would be a little fast. But we are -- we have the supply chain supply to the point where we can be pretty consistent within a certain framework. 190,000 is too high though.

Okay, okay, that's fine. So it's a sort of study. For modeling purposes, we shouldn't assume that you're going to make a bunch and then it's 3 months until you can make a bunch more. Dan, just remind us, did you provide financial guidance for this year?

No, we do not provide financial guidance.

Okay, great. And then...

That's probably not surprising to you.

[Operator Instructions] And our next question comes from Nathan Cali from Noble Financial.

Just a couple of follow-up questions. With regards to you receiving FDA approval for ST-246, how would that revenue then begin to be recognized, since you guys are starting to ship product? Would it be a big lump sum payment of the $433 million broken out into its payment provisions? So in other words, milestone payments that you're receiving now is going to be used for the development process, but the price per course, is that going to be paid in one lump sum payment at the end?

No, no. So the cash flows are different from the revenue recognition. Once we surpass the 500,000 course threshold, we will be paid for the delivery of those 500,000 courses. And then thereafter, as we make deliveries, we'll be paid on a timely basis, a normal net 30-type basis. So the cash flows are going to be different than the revenue recognition.

So you won't -- will you see that on the revenue line, though, as far as after you hit that 500,000 threshold, will you see a revenue line starting to come in?

No. As we mentioned, revenue will be deferred until all the elements of the procurement component are satisfied. I think right now, you see revenue related to development activities. We'll continue to see that. But related to the procurement part of the contract, that will be deferred.

Okay. So the $12.3 million payment, I think it was roughly that, that was pushed into December of 2012 from November. Did you guys receive the payment already?

We have, yes.

Okay. So that's why we didn't see it on the revenue line, because it's deferred revenue?

Correct, yes.

Okay. And so it will be recognized as revenue, but until you meet all the requirements, you guys can't use that money?

No. It will not be recorded as revenue. We will have the cash...

No, the deferred revenue.

It's the another way, I think. It's: we'll have the cash, but it will not be revenue.

Got you. And when do you expect to maybe getting -- maybe get closer. You probably don't have an exact date on when you would get approval, obviously, but when do you guys start to see expectations improve there to where we can get some clarity on approval?

I think speculating on the date of FDA approval is something that we're not going to do. I think it's been encouraging to see the FDA make approvals using the Animal Rule. In just the last quarter, they approved raxibacumab from BMS -- I think it's BMS that acquired Human Genome. So we had been concerned that we might have to be the first company out of the gate to get a new molecular entity approved by the mechanism, but it was encouraging to see that, and we see that the FDA, I think, has been a lot more receptive and interactive on the subject. But to say specifically when that will happen, we can't do that.

Right. And then just one follow-up question to the litigation. This is a factual question, I hope. As far as the litigation goes, if it stays where it is now, 50-50 profit split, the money that you're getting now that's going into deferred revenue, will 50% of that, as based on the breakout, be deferred to PharmAthene? Is that how that's going to work?

The way we'll comment on that is, well, first of all, we have an appeal that's outstanding, and so we want to see what happens there. If in the event, after the appeal, the Chancery Court ruling still stands, we will just follow the ruling of the Chancery Court.

Our next question comes from Joaquin Horton from Sterne Agee.

I'm not going to be redundant. I'm not going to ask how the development is going on Dengue fever and Lassa fever.

I thought you were, today.

Anyway, I assume it's going fine.

I think it is. We -- the last quarter, we think we have made progress. To be specific about it is not something that we're going to do. But our work in both those areas is very active.

Well, good. I want to get back to the IV formulation and its filing an IND, are we there? Are we past there? Or what's the status of that?

We have the IND, so there's one in place right now.

This is for the IV formulation, then?

Yes.

Yes.

Okay. And we're working on a pediatric, or...

Yes. I mean, our development efforts are pretty broad-based for Arestvyr in terms of we have the oral therapeutic, we have the IV, and then there's pediatric and geriatric. So there's a lot of different things. We're balancing them all. So it depends on what we're focused on at that intermediate time. You don't do them all at the same time, but they're all important to us.

But to give you to some color to this, for the pediatric formulation, we're doing things like testing palatability of the API, the active ingredient in various things like apple juice, cranberry juice, others things in which you'd put the API in order to administer to children.

Okay. A question about camelpox and monkeypox and cowpox. I assume that -- this might be wrong, but I assume that with the ST-246 product, this -- it would cure those 3 diseases, correct?

Yes. We've seen -- that's a reasonable conclusion. We have tested Arestvyr against all of the orthopox viruses that -- against which, I'd say, it's reasonably possible to test at least in vitro efficacy in some of them. We've had -- for vaccinia, obviously, we've had animal models. We have not -- there's not an animal model that we've worked with for camelpox. But the molecular mechanism of the drug attacks a specific target that we know is common to all the orthopox viruses. So there's every reason to think that our drug would be accepted in those instances.

Well, in the Scientific American here last month, there was an article about monkeypox in the Congo. And according to one scientist from UCLA, she felt that it was getting to epidemic proportions and starting to spread to the cities now. Would our product be useful?

I think that's a potential use for it, but I think it would be complicated to do. And for us to speculate on it now is something that I don't think we should be doing.

Our next question comes from Fred Greenberg [ph] from GA Advisors.

A couple of quick questions. First of all, the "cash" that you're getting, someone asked in some way is that restricted? I assume you could use it for anything you want.

Correct, yes.

Yes, so this is more of an accounting situation. It's going to show up in cash flow on your balance sheet, like many other companies.

Yes, it will be shown in cash balances.

Okay, that wasn't clear as you presented. What animals are you using for -- we weren't sure whether it was mice, rats, monkeys. Have you decided on the animals that the FDA will at least review?

We have obviously extensive nonhuman primate animal work. There are multiple species in which we have worked in the past, and that includes mice, rats, rabbits and the like. But we're not going to comment about the specific animal species in which we test at any specific time.

The Chancery Court can bifurcate their ruling, I believe, is that correct?

We're not going to speculate on what the Chancery Court can do. I'm sure it can do a lot of things. And it's at the Supreme Court now, not...

I'm sorry, the Supreme Court.

Correct.

It's migrated. The -- do we know of any actual threat? We've seen what's happening in Syria. Has anyone talked or do you know of any actual smallpox threat out there? Leaving out the Congo, which is a different situation.

I don't think we can speak specifically to any threat. This is something that the intelligence community, I'm sure, is actively following...

Your stock price would tell us instantly, wouldn't it?

Excuse me?

Your stock price would tell us instantly if it was out there, probably, better than the community.

We're not going to speculate on any higher number. I think we have said in the past, though, that aside from any potentially existing stores of the smallpox virus, the technology to make it de novo by synthesizing it using available technology which could generate the virus, or modification of viruses like camelpox that are remarkably close genetically. Camelpox differs from smallpox by less than 50 base pairs. And as we've said before, it's more than feasible to change a base pair in a very short period of time by scientists that we think are available all over the world.

Yes, it's a real problem, unfortunately. Any backlash effect, backwash risk from this sequester which came down dramatically, resulting in a lot of instant potential cutbacks? Wouldn't you be in line for being cut back in some way?

Our understanding of our contract is that it's in budgets that are not part of the sequester.

The money funding our contract came from a special reserve fund that was appropriated...

In 2004.

2004. So it was not part of an annual appropriation process. And so that amount has been obligated to our contract.

Okay. And I see you've had some -- I'll give up this phone in a second. Three major or new investors, including GE, which is an investor that I've had in some of my funds. They do a great job in due diligence, and BlackRock and I guess FMR came in, so congratulations.

Thank you.

Thank you.

Our next question is a follow-up from Greg Wade from Wedbush.

Eric, could you just help us to run through the milestones associated with the development activity you're going to do on Arestvyr towards approval this year, and what timeline toward the filing are you working towards?

Well, there are 2 remaining milestones, as I understand. One is obviously the FDA approval.

Greg, are you asking about the contract milestones, or just generally development-wise?

Yes, with development activities. We don't have -- obviously, there's no real clinical study. It's mostly animal model work that's ongoing. So what are sort of the things to be done this year?

Well, probably the highest on our list is to reach the 500,000 course threshold, which we expect to meet by the end of the second quarter. And following that, to continue to produce in compliance with our contract.

I was actually working towards FDA approval. What development activities are taking place this year?

Well, there are multiple development activities that include both animal models and, at some point that we have not yet defined, a pivotal human safety study as well. But that study, because of the remarkably safe toxicology and lack of adverse events in the studies that we've had before, I think there is still a sense that, until there is further animal work, that additional confirmatory human safety studies are not necessary at this point. They're obviously going to be necessary for the FDA approval, but they're not necessary at this point with regard to the procurement.

Right. I mean, I think investors are a little bit in the dark as to like what actually is going to happen this year, what's on the critical path towards a filing and what your timeline assumptions are to an FDA filing. Perhaps you could just run through the key activities that are going to take place, whether they're successes or failures, in each one of those key activities, and tell us what timeline you're working toward to an NDA filing?

Let me say first that we're not going to speak about the specific activities as we work towards a filing, because this is a very new area, I think, for the FDA. And to say that there is a defined pathway like an FTA [ph] or anything else is just not true. As we do the work, we discuss it with FDA, file reports as we acquire the information, and then decide whether or not there are additional studies that should be done or not as we get through those. That's a very active process. In the recent past, it's included, for example, of a repeat exploration of the drug in the natural variola model, a smallpox model. And that, from our perspective, was a dramatic confirmation of the effectiveness of the drug at a dose that we think is comparable to the dose that is now about to be in the Strategic National Stockpile. I think that's information, for example, that's in the process of being digested. And in terms of what further studies should be required in nonhuman primates or any other species is something that I think are still under active discussion. I can't be more specific than that, Greg.

Okay. Well, just one last -- I didn't realize it was such a nebulous process.

Well, I think it was a nebulous process before the panel meeting in December 11. While it's not a specific process, I think it's a very active process and a very iterative process.

Okay. Does the firm have a sort of a plan or a timeline that you're working towards to get to an NDA? And if so, what's your expectation?

We're not going to comment any further on that, Greg.

Our next question is a follow-up from Nathan Cali from Noble Financial.

I just wanted to make sure I got this correct for modeling purposes. In a situation where you may not receive FDA approval, the monies that you generate from the initial 1.7 million courses, that will be recognized as revenue at some point no matter what, even if you don't receive FDA approval? That was -- that's been my understanding all along. I don't know if that's changed or not.

Well, at some point, if it becomes clear that we cannot achieve FDA approval some point in the future, if we get to that point, yes, at some point, the deferred revenue will become revenue. But there would have to -- that would be -- it would be fulfilling one of the elements or remaining element of the contract. That's a point far, far into the future, so we wouldn't really want to speculate about it. But yes, at some point, it becomes revenues, but the preferred path is for them to become revenues in the event of FDA approval.

And is that something that BARDA is making you guys do, or is that something you're doing on your own as far as deferment of the revenues for the 1.7 million courses?

No, this is just GAAP.

Thank you. I'd like to turn it back to Eric Rose for closing remarks.

Thanks, everybody. Appreciate the vigorous questioning today. I think that's reflective of the extent of activities in this past quarter. Again, I think it's been a crucial quarter for us as we move towards the commercialization and becoming a commercial and cash flow positive entity. And we look forward to updating you on our next quarterly update. And I'll turn it back to Todd.

Thank you, Eric. And thank you, all. As a reminder, this call included certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timeline for bringing such products to market and the continued development and possible eventual approval for such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond SIGA's control. Actual results may differ materially from those anticipated in any forward-looking statements. Factors that may cause such differences include the risk that potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent preclinical or clinical trials; SIGA or its collaborators will not obtain appropriate or necessary government approvals to market these or other potential products; SIGA may not be able to obtain anticipated funding for its development projects or other needed funding; SIGA may not be able to secure funding from anticipated government contracts and grants; SIGA may not be able to secure or enforce sufficient legal rights in its products, including patent protection for its products; any challenge to SIGA's patents and other proprietary rights, as is adversely determined, could affect its business, and even if determined favorably, could be costly; regulatory requirements applicable to SIGA's products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products; the U.S. Biomedical Advanced Research and Development Authority may not complete the procurement set forth in its solicitation for the acquisition of the smallpox antiviral for the Strategic National Stockpile, or may complete it on different terms; any contractual award we may receive to supply a smallpox…