Earnings Labs

SIGA Technologies, Inc. (SIGA)

Q4 2013 Earnings Call· Mon, Mar 10, 2014

$4.60

+0.77%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and thank you for your patience. You've joined the SIGA Technologies Quarterly Business Update. [Operator Instructions] As a reminder, this conference may be recorded. I would now like to turn the call over to your host, Managing Partner of KCSA Strategic Communications, Mr. Todd Fromer. Sir, you may begin.

Todd Fromer

Analyst

Thank you, and thank you, all, for joining us today. This is Todd Fromer of KCSA Strategic Communications, Investor Relations Consultant to SIGA Technologies. Hosting the call today is 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 a 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 full year ended December 31, 2013. With that said, I'd now like to turn the call over to Mr. Dan Luckshire. Dan, the floor is yours.

Daniel Luckshire

Analyst

Thank you, Todd. Good afternoon. Thank you, all, for joining us for our business update call. During this call, I will provide you with a business update, and then I will open the call for questions. Before I get into the prepared remarks, I would like to pass along my regards -- or regards from Eric Rose. Eric and I were both planning on being on this call, but Eric has come down with a stomach bug. All of us are subject to getting stomach bugs, and today is his day. So we look forward to Eric joining us for the next call. He's unable to join us for this call. I'd like to start by saying that we are excited about SIGA's future. We believe that we have built a strong, efficient foundation, and we believe there will be opportunities to grow our foundation. The Arestvyr business is the center of our current foundation. In 2013, the Arestvyr business achieved many important milestones. Let me name a few. In March of 2013, we made the first delivery of Arestvyr to the Strategic National Stockpile. This is a major achievement as Arestvyr's a novel small-molecule drug that addresses a very serious biothreat. This achievement was made possible by coordinated progress among our science team, our operations team, our regulatory team and our management team. Our proven ability to coordinate a successful R&D and commercialization effort is a rare and valuable asset. In the third quarter of 2013, we surpassed the 500,000-course delivery threshold, allowing us to receive payments from the government for product deliveries. Since surpassing this threshold, we have received $96 million from the government for the deliveries of Arestvyr. The third thing I'd like to recap is in total, we have delivered approximately 920,000 courses of Arestvyr to…

Operator

Operator

[Operator Instructions] Our first question comes from Joaquin Horton of Sterne Agee.

Joaquin Philip Horton

Analyst

Dan, just a couple of questions. One, did we deliver any ST-246 to the government where they paid us or were the -- all the courses -- part of the 300,000 courses that we had to deliver on a free basis?

Daniel Luckshire

Analyst

You're referring to the fourth quarter?

Joaquin Philip Horton

Analyst

Yes, I am.

Daniel Luckshire

Analyst

Yes. All the courses delivered in the fourth quarter were free of charge.

Joaquin Philip Horton

Analyst

Okay, and so the decrease in the balance sheet from, I think, it was down maybe around $14 million, was that because of -- what reasons?

Daniel Luckshire

Analyst

Culmination of normal operating expenses, as well as we pay a lot of our CMO cost or supply chain costs upfront before deliveries.

Joaquin Philip Horton

Analyst

Okay. So you had a lot of prepaid expense in there then?

Eric Rose

Analyst

Yes, so we had a lot of cash payments, but as we mentioned, in February, we did deliver 256,000 courses, of which 192,000 we will be invoicing for. The value of that 192,000 courses is approximately $25 million. So we -- the cash balance, we expect, will be going up.

Joaquin Philip Horton

Analyst

Okay. As far as, well you can't really tell us how far down the line you are in finding partners for dengue or Lassa or whatever, I did see that the government awarded a contract to someone in Galveston for about $28 million for development of a Lassa vaccine or parvo [ph] vaccine. How are we doing in that area?

Daniel Luckshire

Analyst

So in the area of partnering?

Joaquin Philip Horton

Analyst

Yes.

Daniel Luckshire

Analyst

In the area of partnering, it's -- these things do take some time. What I would say is we're not going to comment specifically about that the process is active. We're having conversations in due diligence with multiple parties.

Joaquin Philip Horton

Analyst

Okay. Now after the layoffs, how -- at the end of the year, how do you feel the morale is in the company?

Daniel Luckshire

Analyst

Right. Whenever you go through a process of optimization and refocusing resources and losing some good people as that can be tough, but the good thing is that we have a lot of long-standing key employees that are driving the signs forward in Corvallis and they're still in place and they've been -- they've seen a lot and they are committed to the program. And so I would say that morale is good. It's tough to go through any change, but we've gone through a lot of change over the years and it's very integrative -- innovative and robust group in Corvallis, so the way they've handled this is commendable, and we're moving forward at the normal fast pace.

Joaquin Philip Horton

Analyst

Yes, I did see that you guys got a patent on the Lassa fever molecule.

Operator

Operator

[Operator Instructions] Our next question comes from Nathan Cali of Noble Financial.

Nathan Cali

Analyst

Just a couple of quick follow-up questions. So is there any expectation on approval time for FDA approval?

Daniel Luckshire

Analyst

We -- what I would just say is that, as we mentioned, the Animal Efficacy Rule, it is a complex framework. And have -- going through the complex framework, we don't provide timing estimates on that. What I would say is that the timeline for the regulatory process is longer than the timeline for the product delivery that we are making right now. And one thing to keep in mind as we go through the Animal Efficacy Rule is it's iterative, and we're under this concept of triangulation. And triangulation means using a variety of models to build a case for FDA approval, and as you go through and you do one step, the results of that determine how much more steps you have to take to build your case before you can go for FDA approval. So it's an iterative process and we continue to pursue it diligently and look for every opportunity possible to be efficient and move it as quickly as possible.

Nathan Cali

Analyst

Okay. So you've got about half of the contract delivered and you're expecting to deliver the remaining this year?

Daniel Luckshire

Analyst

By the end of the first quarter of 2015.

Nathan Cali

Analyst

By the end of the first quarter of 2015, okay. And then has BARDA or the government indicated any additional contracts that may be coming along where you guys could offer more of your product to the stockpile?

Daniel Luckshire

Analyst

No, it's the government contracting process, it's not transparent. We'll have to wait for an RFP to really have any view on that. We're doing what we can to put ourselves in the best position, including delivering quality product on a timely basis. We do believe that there's a case that the SNS should have more than 2 million courses. But ultimately, that's BARDA's decision, and as I mentioned, it's an opaque process so we don't have any insight into that.

Nathan Cali

Analyst

And then IV in pediatrics formulation, are you still moving forward with that?

Daniel Luckshire

Analyst

Yes, we're still focused on IV, as well as oral suspension.

Nathan Cali

Analyst

Okay. Now is that process the same as going forward and getting FDA approval for the oral formulation? Would you have to have FDA approval prior to stockpiling that? Or they've indicated that they have interest in stockpiling the IV formulation pre an FDA approval?

Daniel Luckshire

Analyst

I would say that it's possible that they could approve -- BARDA's mandate is to purchase unapproved product versus -- I think it gets into another bucket once you're approved. I don't think we would have to be approved in order for BARDA to make an acquisition of IV or oral suspension.

Nathan Cali

Analyst

And is there any status update on that, the IV formulation?

Daniel Luckshire

Analyst

No status update on that right now.

Operator

Operator

At this time, I'd like to turn the call back over to management for any closing remarks.

Todd Fromer

Analyst

Okay. 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 or potential of 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 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, 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 a 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 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…

Operator

Operator

Thank you, sir, and thank you, ladies and gentlemen, for your participation. This does conclude SIGA Technologies' quarterly business update. You may disconnect your lines at this time. Have a great day.