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SIGA Technologies Inc.
5/6/2021
During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star and zero. As a reminder, this conference is being recorded. Before we turn the call over to see the medicine, 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 statement. 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's for the year ended December 31, 2020, and its subsequent reports on Form 10Q and Form 8K. I would now like to turn the conference over to Phil Gomez, Chief Executive Officer. Please go ahead.
Thank you for taking the time to join today's call. Today I'm joined by Dan Luckshire, our CFO. Dan and I are pleased to have this opportunity to provide a quarterly update on our business and upcoming objectives. On this call, I will provide a business update and Dan will provide a financial update. We'll then be happy to take any questions you may have. The first quarter of 2021 reflects our continuing momentum for international sales. We delivered approximately $3 million worth of oral teapots to the Public Health Agency of Canada, PHAC, in the first quarter. And in April, we delivered an additional $7 million worth of oral teapots to PHAC. Supplementing these international deliveries, we are working towards further sales to one or more new jurisdictions in 2021. with the second quarter being the most likely scenario for the next sale. As general background on the international market, I would like to reiterate comments from the last investor call. While we are currently having success in generating international orders this year, we expect the pandemic will continue to subject SIGA to the risk of international business development activities coming to fruition slower than anticipated. In contrast, post-pandemic, we believe that international governments will be better situated in terms of resources, experience, focus, and personnel to fully appreciate the importance of health security preparedness and the value that oral TPOX provides in that context. As such, we believe that the post-pandemic environment should have a net positive impact on our international business development success. In sum, we expect international sales in 2021 may be concentrated in the first half of the year and gain additional momentum in 2022. With respect to the BARDA-19C contract, we continue to expect sales related to this contract, based upon an option exercise, to be concentrated in the second half of 2021 as the new administration leadership gets confirmed and COVID-19 response activities hopefully become less burdensome on the staff with whom we work on our programs. Like many people here in the U.S., we are encouraged by the progress in addressing COVID-19, especially the rapid rollout of vaccines led by our government partners at BARDA and the ASPR office at HHS. We know this year has been extremely challenging, especially for them as well as many others, but support for the development and rollout of the vaccines has been an amazing accomplishment. With regard to the pandemic, we continue to monitor its impact on our operation. As a general comment, we as a company have done a good job navigating the uncertainty of the pandemic. The filing of our intravenous formulation of TPOX with the FDA announced this week is an example of continuous, steady progress toward our corporate objectives amidst the evolving environment. And concurrent with the FDA filing process for IV teapots, we have started commercial manufacturing for IV teapots with a goal of delivering this year approximately 20,000 IV courses of teapots under the base period activities within the 19C contract. As referenced, the revenue value of 20,000 IV courses is $8 million. As we look at planning for IV teapots in the context of option exercises under the 19C contract, It should be noted that the production of COVID-19 vaccines has significantly impacted the availability of materials for sterile products. This includes items like vials, filters, excipients, among other things. We will work with BARDA should they exercise options for IV TPOCs in terms of securing necessary supplies and manufacturing capacity. In the interim, we are able to fully support the $1.7 million core stockpile with oral courses as long as we receive option exercises in a timely manner. At this point, I'd like to take a few minutes to talk about our new partnership with Cipro Therapeutics. By way of background, there are a number of products that the U.S. government is seeking to support through development and procurement for the Strategic National Stockpile, or SNS. One category is novel antibiotics to replace the generic antibiotics in the SNS for bacterial pathogen threats. For example, in 2019, the U.S. government awarded a contract for a novel antibiotic which potentially could be used for a biodefense indication. This contract includes up to approximately $150 million of procurement funding, as well as over $100 million of potential development funding. Last year, BARDA issued a Request for Information, or RFI, for other potential novel antibiotics, which could potentially lead to a contract award similar to the award made in 2019. As such, we have teamed with CIPLA to pursue a potential future RFP in this area. As background, CIPLA's antibiotic Xemdry is approved by the FDA in the U.S. for a commercial indication, but was supported by BARDA during its development for treatment of bacterial threats. In the collaboration with CIPLA, we are seeking to leverage our extensive expertise in animal rule product development to support new biodefense indications for Xemdry and to be the prime contractor with the U.S. government if there is a contract award. In turn, CIPLA brings to the table Zemdry and extensive experience with manufacturing and a global supply chain. In addition to the near-term focus on a potential RFP, we continue to look for additional opportunities to collaborate with CIPLA and other companies to bring needed products to the U.S. government. I'll now pass the call over to Dan, who will provide a financial update. Dan?
Thanks, Phil. As noted earlier in the call, We expect international sales likely to be concentrated in the first half of the year and sales to the U.S. government to be concentrated in the second half of the year following an option exercise. As such, product revenues for the first quarter reflect approximately $3.4 million of international oral TPOX deliveries. This amount already surpasses total international sales for the entirety of last year. Total revenues for the quarter, including research and development-related revenues, were approximately $4.8 million. Operating loss for the first quarter, which excludes interest income, taxes, and adjustments to the fair value of the warrant, was approximately $2 million. Net loss for the first quarter was approximately $1 million. In turn, FOIA diluted loss per share was 2 cents per share for the quarter. At March 31st, the cash bounce for the company was approximately $107 million. But during the first quarter, Tega repurchased approximately 1 million shares of its common stock for approximately $6.5 million. As of March 31st, 2021, the company has cumulatively repurchased approximately 5.6 million shares of its common stock since the inception of the Share Repurchase Program in March of 2020. Looking beyond the first quarter financial results, there remains approximately $450 million of TPOC's procurement revenues tied to existing contracts, most of which is currently expected to be earned approximately over the next four years. That is, between March 31st, 2021 and the end of 2024. These revenues would come from the 19C BARDA contract and the Canadian contract, with the 19C BARDA contract containing up to $414 million of procurement-related options remaining for future exercise by BARDA. In April, the company delivered approximately $7 million of Royal Teapots to the Public Health Agency of Canada, under an existing contract. Such amount will be included in the second quarter financial results. 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'll pass it back to Phil for a brief summary.
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