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SIGA Technologies, Inc.

SIGA US

SIGA Technologies, Inc.United States Composite

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Q4 2011 · Earnings Call Transcript

Mar 1, 2012

Operator

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.

Todd Fromer

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; and Daniel Luckshire, the CFO.

Todd Fromer

Today's call is being simultaneously webcasted and is available on SIGA's website. A replay of the call will also be available in a recorded format on the company's website.

Todd Fromer

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 on our press release for financial results for the year ended 2011.

Todd Fromer

With that said I'd like to turn the call over to Dr. Eric Rose.

Eric, the floor is yours.

Eric Rose

Thanks, Todd. Good afternoon, and thank you, all, for joining us for our business update call.

During this call, Dan Luckshire and I will provide you with a business update, and then we will open the call for questions.

Eric Rose

Since our last call in November, we have continued to march forward on schedule in the performance of our BARDA procurement contract. We've recently completed the required security implementation at our lead manufacturing site, and we're commencing compound synthesis of drug substance of ST-246 at the site tomorrow, actually.

In sum, we continue to be on schedule to start delivering product produced under BARDA-approved security arrangements by the end of the first quarter of 2013. Once we start delivering product, we expect to deliver the full 2 million courses of drug within 24 months of the initial delivery date.

Depending on a series of factors, the size of each delivery and the exact timing of each delivery will be determined in the future. Once we deliver 500,000 courses, we will be able to invoice for payment.

Eric Rose

Please note that, when I talk about delivery date, the discussion is focused on product that is produced under BARDA-approved security arrangements as opposed to product that is produced outside of these security arrangements, such as courses produced as part of the commercial validation process.

Eric Rose

On the regulatory front, we participated in December in a 2-day Advisory Committee Meeting convened by the FDA to discuss development paths for drugs that treat smallpox, including the preferred animal models to determine the efficacy of these drugs. In aggregate, we found the responses and views of the committee panel members to be practical and constructive.

Importantly, the advisory committee's recommendations confirmed that monkeypox, rabbitpox and ectromelia models, especially in combination, could suitably provide appropriate evidence of efficacy for treatment of smallpox. This is important to us because animal testing to date has shown that our drug ST-246 is highly effective in all of 3 of these models.

Eric Rose

Subsequent to the December Advisory Committee Meeting, we've been communicating with the FDA regarding the development path of our drug, and we expect to engage further with the FDA on this topic in the coming months.

Eric Rose

In addition to our regulatory development work on the oral formulation of ST-246, we've also continued our IND-enabling work on the intravenous or IV formulation of the drug. We continue to target an IND filing for the IV formulation as early as the fourth quarter of this year.

Eric Rose

At this point, I'm going to hand the call over to Dan, who will provide an update on our financial position and an update on the PharmAthene litigation.

Daniel Luckshire

Thank you, Eric. Regarding our financial position, we had $49.3 million of cash on our balance sheet as of December 31, 2011.

This amount is meaningfully larger than cash balances historically maintained by SIGA and reflects our growing footprint as a commercial-stage company. The cash balance will be invested in the performance of the BARDA contract and the funding of SIGA's business operations.

Daniel Luckshire

In addition to having cash on hand, we are also targeting a $12 million labeling plan milestone for the summer of 2013 (sic)[ 2012 ]. Cash from this milestone as well as cash received from continuing development contracts and grants should buttress our near-term resources.

Daniel Luckshire

With respect to the PharmAthene litigation, both SIGA and PharmAthene have submitted their own separate definitions of net profit to the court. As a reminder, definitions of net profit and of the components that lead up to the calculation of net profit are needed in order for a final judgment to be entered in accordance with the post-trial ruling of the Chancery Court.

The parties have also each made various submissions to the Chancery Court in support of their respective definitions.

Daniel Luckshire

There are substantial differences between the parties' approaches to net profit and the appropriate implementation of the Chancery Court's post-trial ruling. And clarity on the impact of these rulings on SIGA will have to await the final ruling by Vice Chancellor Parsons.

Once the court enters a final judgment implementing a net profit definition, we will evaluate this judgment and determine the best course for SIGA going forward, including the possibility of an appeal of the decision and judgment to the Delaware Supreme Court.

Daniel Luckshire

This concludes our prepared remarks. Thank you for attending this business update, and we will now open the line for questions.

Operator

[Operator Instructions] And our first question comes from Joaquin Horton [ph] from Sterne, Agee.

Unknown Analyst

Eric, in past conference calls, you've talked about filing INDs for both dengue and Lassa fever. Can you bring us or give us an update on how those 2 programs are going?

Eric Rose

We're pleased with the progress of both of those programs and we're still optimizing, particularly in the dengue program. We have a plethora, if anything, of potential drug candidates and families of drug candidates so I think that for that program, and for that matter, for the Lassa program either, I think, to specify exactly when we'll do IND filings is not something we're prepared to do yet.

Unknown Analyst

Okay, but you've done that in the past phone calls. I mean, you've kind of given us a clue, but it sounds like things have changed a little bit or...

Eric Rose

I don't think things have -- our view of these programs, I don't think, has changed. I think the specificity that we can give in this regard is something that we don't think we ought to provide at this point.

Unknown Analyst

Okay. In the press recently, there's been some talk about some scientists creating a deadly man-made bird flu, and I guess that's H1N1.

In our broad-spectrum program, are we doing anything to look at this?

Eric Rose

The broad-spectrum program, I -- it is not particularly focused on influenza. We do have a high-throughput screening program with regard to influenza virus, though, that is underway, which could be applicable to this.

But we certainly are not working with a virus with these characteristics. And we shouldn't be.

It's a safety issue, for sure.

Unknown Analyst

Okay. What is the next thing as far as getting together with the FDA?

Are you going to have a meeting, or are they going to -- is it just continuing negotiations or...

Daniel Luckshire

Yes, this is Dan, and I'll just answer that. As to the advisory committee, we've had an active dialogue with the FDA and we plan on continuing to have this active dialogue with the idea of this culminating into a specific development path in the future.

In terms of the specific time frame, it'll probably be premature to count on it, other than we feel like the conversations are constructive and it's building to something substantial.

Unknown Analyst

Okay. Last November, Secretary of State Hillary Clinton gave a speech on bioterrorism and brought up Syria as being a country that has developed something along the camelpox area.

And recently, 1st of January, there was an announcement that the London emergency response team for the Olympics had somewhat, like, over 300 members had been vaccinated for smallpox. Now it seems to me that something has changed here.

I've never even heard of a response team being vaccinated for smallpox. Have we had any conversations with any governments recently that would lead us to believe that there's something going on?

Eric Rose

I -- we don't comment on specific conversations that we're having with governments. Regardless of this, of the London Olympics, we sense that there is a considerable international interest in the risks of orthopox viruses as weapons of mass destruction and making sure that they don't become such.

And that has not changed.

Unknown Analyst

And just a last question. And all these investigations that were thrown at you, from Darrell Issa to Senator McCaskill to the Energy and Commerce Committee -- well, actually they weren't thrown at you but thrown at BARDA.

Have you heard anything on the resolution of any of those investigations?

Eric Rose

Well, to our knowledge, there have been no investigations. There have been requests for information to BARDA and, at least our understanding is that they've received copious amounts of materials from BARDA.

And we've seen no further statements on the part of any of those committees or bodies. And as far as we know, we have not seen any further activities from them since they've gotten that information.

Operator

[Operator Instructions] And our next question comes from Fred Greenberg [ph] from Greenberg Advisors [ph].

Unknown Analyst

A couple of quick questions. On the dengue, can you tell us which, governments or non-profits or WHO, aren't those agencies working on a vaccine for dengue at this point?

I know dengue, at least from my understanding, is a very complex target. I wonder if you agree with that.

So there's 2 questions in there.

Eric Rose

Well, first on the issue. We know there's industry activity with regard to dengue virus development that I believe it's sanofi-aventis that's developing a vaccine.

So I can't say specifically if there are international government entities that are supporting...

Unknown Analyst

How far along is their vaccine, do you know?

Eric Rose

My understanding is they're building a plant for it, so I think it's something that is moving along.

Unknown Analyst

So if they're building a plant, it seems like they're very far ahead of you.

Eric Rose

I don't think that a vaccine, as compared to an antiviral, is exclusive -- excludes the potential utility of an antiviral. And there are a lot of hurdles to be overcome to develop a successful vaccine, as there are to develop a successful antiviral as well.

But we certainly don't view the development of a vaccine as something that would keep us from our commercial interests in pursuing dengue.

Unknown Analyst

What can you say about the price for the ST-246? You gave us the courses but you didn't say anything about price.

Daniel Luckshire

The pricing for...

Eric Rose

ST-246, yes.

Unknown Analyst

Yes, for the 2 million courses.

Daniel Luckshire

Well, the, that, you can, the information we're going to disclose on the pricing is in the redacted contract that's been filed.

Unknown Analyst

Well, what is it, we don't know. If it's redacted, we can't see it, right?

But you talked about it, the price per course. Is it the same, or has it changed, or what?

Daniel Luckshire

Fred, the definition that we're disclosing is in the contract that was filed.

Eric Rose

And it hasn't changed.

Daniel Luckshire

It hasn't changed.

Unknown Analyst

Okay. Make it simple.

The -- and in this year -- not 2012, that's[ph] '13, are we expecting any contracts of any kind? Any income?

Daniel Luckshire

Well, to your point, I'm glad you brought that up. We are talking about this.

On the, in our prepared remarks, we were talking about the labeling plan milestone. That is summer of 2012.

Unknown Analyst

Because I think you said '13, didn't you?

Daniel Luckshire

You're correct. We were just talking about that.

It is...

Unknown Analyst

Because I was talking to someone else who really knows this area, and he said 2012, so okay.

Daniel Luckshire

Yes, so...

Eric Rose

2012 is correct.

Daniel Luckshire

It is correct. So to again state: It is, the labeling plan milestone is the targeted for the summer of 2012.

Unknown Analyst

Okay. Now is there anything else in that category or related to do that?

Daniel Luckshire

So beyond that, most of 2012 will be used for producing drug. There is a second milestone related to commercial validation.

Our anticipation would be that...

Unknown Analyst

That's a BARDA milestone.

Daniel Luckshire

That is a BARDA milestone, that $8 million, but that would be likely a 2013 event.

Daniel Luckshire

[Technical Difficulty]

Unknown Analyst

500,000 courses. Yes, I -- we deliver 500,000 courses, and then bill.

Is that 30 days, net 10? Or is that something different than a regular commercial billing?

Daniel Luckshire

Yes. So you're correct in that we will be able to invoice once we deliver 500,000 courses.

And it's not directly in the contract but most government contracts are net 30.

Operator

And before taking any further questions, Mr. Luckshire would like to make a comment.

Daniel Luckshire

I think the comment that we were planning to make was addressed in the Fred's question about the labeling plan milestone, which to clarify, to be a target for summer of 2012.

Operator

And I'm showing no further questions in the queue. I'd like to turn the conference back to Mr.

Todd Fromer for closing remarks.

Todd Fromer

Thank you. As a reminder, everyone, 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 or potential of products, the time line for bringing such products to market and the continued development and possible and eventual approval for such products.

Forward-looking statements are based on management 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 risks 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.

Todd Fromer

SIGA or its collaborators will not obtain appropriate or necessary governmental 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, if it's 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 SIGA -- delay or prevent seeking or obtaining needed approvals to market these products.

Todd Fromer

The U.S. Biomedical Advance Research and Development Authority may not complete the procurements set forth in its solicitation to 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 antiviral may be subject to one or more protests, which may cause contract awards to be delayed or denied.

Todd Fromer

The volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts. Changes in domestic and foreign economic market conditions may adversely affect SIGA's ability to advance its research or its products and the effect of federal, state and foreign regulation on SIGA's businesses.

Todd Fromer

More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this conference call, are set forth in SIGA's filings with the Security and Exchange Commission, including SIGA's annual report on Form 10-K for the fiscal year ended December 31, 2011, and in other documents that SIGA has filed with the commission. SIGA urges investors and the security holders to read these documents free of charge at the commission's website at www.sec.gov.

Interested parties may also obtain these documents free of charge from SIGA. Forward-looking statements speak only to the date they are made.

And, except for any obligation under the U.S. Federal Securities laws, SIGA undertakes no obligation to publicly update any forward-looking statements as a result of new information, future events or otherwise.

Todd Fromer

This concludes our call. You can now disconnect your lines.

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may all disconnect at this time.

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