SIGA Technologies Inc (SIGA) 2014 Q2 法說會逐字稿

Good day, ladies and gentlemen and welcome to the SIGA Technologies Quarterly Business Update Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host Mr. Rob Fink of KCSA Investor Relations. Mr. Fink, you may begin.

Thank you. And thank you, all, for joining us today. This is Rob Fink of KCSA, Investor Relations Consultant of SIGA Technologies. Hosting the call today is Dr. Eric Rose, Chief Executive Officer; Daniel Luckshire, our 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 recorded format on the Company's website.

Before we begin today, I would like to remind everyone that this conference 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 the Company's press release for financial results for the second quarter ended June 30, 2014.

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

Thanks, [Rich]. Good afternoon and thank you all for joining us. Let me start with an update on the biodefense business. In July, approximately 115,000 courses of Tecovirimat or ST-246 were accepted into the Strategic National Stockpile. With the delivery and acceptance of these courses, we received $15.3 million in July pursuant to our procurement contract with BARDA. Cumulatively as of the end of July, we've delivered 1.3 million courses of Tecovirimat and we have received close to $200 million from the BARDA contract, excluding expense reimbursement payment.

Going forward, we plan to deliver approximately 710,000 courses by the end of the -- additional courses by the end of the first quarter of 2015 which we expect would generate additional gross proceeds of $89 million. Moreover SIGA is eligible under the BARDA contract for an additional approximately $123 million of payments for the successful submission and approval of the Tecovirimat NDA.

I'd like to note that FDA approval of Tecovirimat is strategically important to SIGA. We believe that FDA approval will aid our international business development efforts and may make additional domestic markets viable.

Beyond the biodefense business, I'd like to talk about another avenue for value creation, strategic investment. We believe that acquiring, in-licensing or collaborating on clinical stage development programs could expand and broaden SIGA's scope and could offer a favorable time horizon for value creation.

Additionally and importantly, strategic investments could also benefit from being supportive and supplemented by SIGA's existing infrastructure and expertise. Potentially adding clinical stage development programs to our existing biodefense business would represent a natural continuation of SIGA's long-term evolution, the evolution started three years ago with the signing of the BARDA contract. It's been pushed along through diligent performance on the contracts and its focus has been sharpened with the optimization program that was put in place late last year. The end goal of the evolution is to use SIGA's infrastructure, expertise and resources to maximize long-term value.

At this point we've completed our prepared remarks for our business operations and we'll now open the line for questions.

(Operator Instructions) Joaquin Horton, Raymond James.

I just want to ask a couple of questions. Also nine months ago, you mentioned that you are going to try to license or do something with the products that we had developed like dengue fever and Lassa fever and the other projects we were working on like Ebola. Have we had any success in marketing that idea or licensing it?

We have not completed any transaction with regard to any of those programs. But as we said then it still remains the case now that that is our intention and we've been actively seeking such collaboration.

In the number of courses that we're going to deliver, the 710,000, how many of those courses are going to be -- I know we have to deliver 300,000 pursuant to the contract earlier without receiving any payment, and I believe something over 250,000 has already been delivered. Is that correct?

That is correct, Joaquin, and this is Dan. Of the 710,000, 670,000 approximately are -- will be delivered invoice. [That is 40,000 will be] free of charge.

Okay. That's all the questions I have. Thanks.

Thank you.

(Operator Instructions) All right. I'm not showing any further questions. Please proceed with any closing remarks.

Great. Thank you. 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 to continue 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 of potential products that appear promising to SIGA where its collaborators cannot be shown to be effective or safe in subsequent preclinical or clinical trials. SIGA or its collaborators will not obtain appropriate or necessary governmental approval to market these or other potential products. SIGA may not be able to obtain anticipated funding for its development projects or other fund needed. 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 challenges 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 deploy or prevent seeking or obtaining needed approvals. 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 incomplete it on different terms. Any contractual award we may receive via smallpox antiviral may be subject to one or more protests, which may cause the contract awards to be delayed or denied. The volatile and competitive nature of biotech industry may hamper SIGA's efforts, changes in domestic and foreign economic marketing conditions may adversely affect SIGA's ability to advance its research or its projects and may affect federal, state and foreign regulation on SIGA's business.

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, is set forth in SIGA's filings with the SEC, including SIGA's annual report on Form 10-K for the fiscal year ended December 31, 2013 and in other documents SIGA has filed with the Commission.

In addition, the risk of what appears now to be attributes of our lead candidate compound may turn to be different as development progresses, the risk that our lead candidate compound may not at any point fail to meet our development objectives and the risk that the expense, unpredictability and extraordinarily time-consuming process of developing drugs may prevent us from ever realizing any value of these efforts.

SIGA urges investors and security holders to read these documents free of charge at the Commission's website at sec.gov. Interested parties may also obtain these documents free of charge from SIGA. Forward-looking statements speak only for the date they are made, and except for any obligation under U.S. federal security laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

Operator, that now concludes the call. Thank you for joining us.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.