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DATE
Thursday, May 7, 2026 at 4:30 p.m. ET
CALL PARTICIPANTS
- Chief Executive Officer — Diem Nguyen
- Chief Financial Officer — Daniel J. Luckshire
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TAKEAWAYS
- Total Revenue -- Approximately $6 million, comprised of $1 million from IV TPOXX product deliveries to the Strategic National Stockpile (SNS), $2 million from manufacturing technology transfer reimbursement revenues, and $3 million from research and development revenues (with subtotals clarifying product-related vs. R&D revenue streams).
- Pretax Operating Loss -- Approximately $5 million, excluding interest income and taxes.
- Net Loss -- Approximately $3 million for the reported period.
- Diluted Loss Per Share -- $0.05 for the three months ended March 31, 2026.
- Cash Balance -- $146 million as of March 31, 2026, with no debt.
- Special Dividend -- A cash dividend of $0.60 per share was declared on March 26 and paid on April 23, 2026; pro forma cash balance remains above $100 million following payout.
- Q2 Revenue Outlook -- Management expects approximately $13 million of oral TPOXX deliveries to an Asia-Pacific customer in the second quarter, alongside additional IV TPOXX deliveries to the SNS.
- International Expansion -- The company entered into an exclusive license and distribution agreement with Hikma MENA FZE, granting Hikma rights for TPOXX across the Middle East and North Africa region, with SIGA as exclusive manufacturer and supplier.
- Development Pipeline Progress -- IND filed and Phase 1 study initiated for pediatric formulation, with results expected in the second half of 2026; post-exposure prophylaxis (PEP) program targeting FDA submission within the next 12 months.
- Regulatory Developments (Europe) -- CHMP reaffirmed TPOXX’s benefit-risk balance for smallpox, cowpox, and vaccinia complications, while recommending withdrawal of the MPOXX indication; the company is taking action to implement this guidance.
SUMMARY
SIGA Technologies (SIGA +0.64%) initiated a pivotal international TPOXX partnership by securing an exclusive distribution agreement with Hikma MENA FZE for the MENA region, augmenting its global reach. The company’s receipt of a $13 million Asia-Pacific order, anticipated for Q2 delivery, signals accelerating international demand and backlog visibility. Early-stage data generation for pediatric and new PEP indications remains underway, indicating sustained investment in product lifecycle extension. Management highlighted the dividend as a capital allocation decision calibrated for ongoing variability in contract cycles, emphasizing financial flexibility. Europe’s CHMP maintained TPOXX’s major smallpox indications but initiated withdrawal for MPOXX, which SIGA is actively managing for compliance.
- Management noted, "The 2026 period reflected a variable rhythm inherent to our business," underscoring the lumpy nature of revenues due to timing of government procurement cycles.
- The company positioned its U.S. government alignment as a core strategic advantage, referencing domestic manufacturing and guaranteed lowest pricing for oral TPOXX to U.S. agencies.
- On Hikma, management stated, "TPOXX will be sold at a price set forth in the agreement. SIGA Technologies, Inc. may also be entitled to additional payments under certain conditions. The financial terms of the agreement are confidential and will not be further disclosed," clarifying the business model and emphasizing potential upside contingent on milestone-based triggers.
- U.S. government funding of $27 million in 2025 supported pediatric formulation work and IV technology transfer, described by management as a "strong signal" of TPOXX’s continuing relevance in federal preparedness.
INDUSTRY GLOSSARY
- TPOXX: Brand name for tecovirimat, an oral antiviral medication specifically indicated for smallpox treatment and other select orthopoxvirus infections.
- IV TPOXX: Intravenous formulation of tecovirimat for non-oral administration, targeting patients unable to take oral medications.
- SNS (Strategic National Stockpile): U.S. federal repository of pharmaceuticals and medical supplies designed for emergency deployment.
- CHMP: Committee for Medicinal Products for Human Use, the scientific advisory body for the European Medicines Agency responsible for assessing and providing recommendations on medicinal products.
- MPOXX: Indication for the use of tecovirimat to treat monkeypox virus infection; distinct from the approved smallpox indication.
- PEP (Post-Exposure Prophylaxis): Preventive treatment administered to individuals after potential exposure to a pathogen, in this case, smallpox or related orthopoxviruses.
- IND (Investigational New Drug): U.S. FDA submission required to obtain approval to start clinical trials for a new drug or new drug indication.
- Hikma MENA FZE: Subsidiary of Hikma Pharmaceuticals focused on pharmaceutical distribution and commercialization in the Middle East and North Africa.
Full Conference Call Transcript
Diem Nguyen: Good afternoon, everyone, and thank you for joining today's call and review of our business results. I am joined by Daniel J. Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we will be happy to answer your questions. SIGA Technologies, Inc.'s focus remains unchanged: partnering with governments around the globe to build and strengthen long-term preparedness strategies against potential biological threats, specifically smallpox. We are proud to supply our smallpox antiviral treatment to many countries and NGOs, and we remain committed to ensuring that TPOXX is positioned for rapid, large-scale deployment whenever it is needed to help save lives. The case for preparedness has never been stronger.
Smallpox and other high-consequence threats, whether the result of an accident, a deliberate act, or a natural occurrence, represent a real and serious threat that can be managed only with proactive, sustained investment. Stockpiling medical countermeasures is a cornerstone of preparedness strategies. And in today's environment of rising geopolitical tension, accelerating technological risk, including those enabled by AI tools, and growing biological threats, the urgency to make that investment is clear. We believe TPOXX is uniquely suited to meet the smallpox threat with a well-established safety profile and targeted mechanism of action that supports broad use in emergency situations. The 2026 period reflected a variable rhythm inherent to our business. Activity levels vary quarter to quarter.
The first quarter had minimal product deliveries, whereas in the second quarter, we expect to deliver approximately $13 million of oral TPOXX to an international customer, as well as make additional IV TPOXX deliveries to the SNS. As a reminder, given this quarter-to-quarter variability, we recommend that our results be viewed in the context of our longer-term performance rather than in isolation. We believe our long-term outlook continues to offer substantial opportunities. This belief is grounded in the fundamentals of our business and the enduring need for governments to protect against biological threats. We continue to maintain engagement with the U.S. government, particularly key stakeholders at HHS.
Although the pace of progress toward a new contract with the U.S. government has been slower than prior contract processes, we believe the $27 million in funding secured in 2025 to support pediatric formulation development and IV TPOXX technology transfer efforts, as well as the 2025 IV TPOXX order, are strong signals highlighting the continued role TPOXX is expected to play in U.S. biothreat preparedness. It is worth reiterating that SIGA Technologies, Inc.'s operating model is closely aligned with U.S. government priorities. Specifically, the U.S. government receives our lowest price for oral TPOXX, and our active pharmaceutical ingredient and all finished drug products are manufactured domestically.
Turning to our international business, we continue to engage with governments and other key stakeholders around the world who continue to review their preparedness strategies and funding. Strategic stockpiling remains central to those conversations. Government procurement is a deliberate process. That said, discussions continue, and we see potential for additional international sales over time. As noted last quarter and earlier on this call, we received a $13 million order from a country in the Asia-Pacific region which we expect to deliver in the second quarter of this year. We also took important steps towards potential sales in a region where SIGA Technologies, Inc. has historically been underrepresented.
We recently entered into an exclusive license and distribution agreement with Hikma MENA FZE. They give Hikma the right to register and commercialize TPOXX across the Middle East and North Africa, or MENA. Under the agreement, SIGA Technologies, Inc. will serve as the exclusive manufacturer and supplier of finished product for Hikma. This agreement represents a key step in our strategy to broaden global access to TPOXX, and Hikma is the right partner for it. Their unparalleled regional presence and deep expertise in bringing innovative medicines to market make Hikma well positioned to bring TPOXX to these markets. Turning to our pipeline, we continue to advance our post-exposure prophylaxis, or PEP, and pediatric programs.
On the pediatric program, we filed our IND and initiated a Phase 1 study. Results are expected in the second half of this year, which will inform next steps. On the PEP program, the CDC continues work on the analysis of immunogenicity samples. We are targeting an FDA submission for the PEP indication in the next 12 months. Looking forward, we remain focused on what has always driven this business: financial and operational discipline, and building on the partnerships that position SIGA Technologies, Inc. for long-term success. As we move further into 2026, we do so with a clear sense of purpose.
The global need for biological preparedness is real and growing, and SIGA Technologies, Inc. is prepared to meet it. We have a product approved by regulators around the world, strong government relationships, and a team that executes. We look forward to continued progress and to updating you along the way. I will now turn the call over to Daniel J. Luckshire for the financial results.
Daniel J. Luckshire: As noted earlier in the call, the company had minimal product deliveries in the first quarter, reflecting the variable rhythm of SIGA Technologies, Inc.'s business model. Product revenues for this quarter include approximately $1 million of IV TPOXX deliveries to the SNS and approximately $2 million of reimbursement revenues in connection with the manufacturing technology transfer. In addition to product-related revenues in the first quarter, the company also had research and development revenues of approximately $3 million. As I talk about revenues, I would like to highlight that we expect second quarter product revenues to reflect the delivery of approximately $13 million of oral TPOXX to an international customer, as well as additional IV TPOXX deliveries to the SNS.
Returning to the first quarter financial results, pretax operating loss for the quarter, which excludes interest income and taxes, was approximately $5 million, and net loss for this period was approximately $3 million. In turn, fully diluted loss per share for the three months ended 03/31/2026 was $0.05. The company continues to maintain a strong balance sheet. As of 03/31/2026, the company had a cash balance of approximately $146 million and no debt. Based on the company's substantial cash balance, a special cash dividend of $0.60 per share was declared on March 26 for shareholders of record as of April 7. The special cash dividend was paid on April 23. This concludes the financial update.
I will now turn the call back to Diem Nguyen.
Diem Nguyen: Thank you, Dan. We will now open the call for questions.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Your first question comes from Jyoti Prakash with Edison Group. Please go ahead.
Jyoti Prakash: Hi, good afternoon, and thanks for taking my questions. My first question is related to CHMP's recent recommendation that TPOXX should not be used for MPOXX treatment. Now this is largely expected, and you had also guided for this previously. But do you see any impact of this decision on TPOXX's broader labeling in smallpox and other orthopoxviruses in Europe?
Diem Nguyen: Jyoti, thank you so much for asking the question. Just as a reminder for those on the call, we had shared earlier that the CHMP has confirmed the positive benefit-risk balance of tecovirimat, which is known as TPOXX in Europe, as a treatment for smallpox, cowpox, and vaccinia complications. Those indications have been reaffirmed by CHMP. And as you mentioned, the CHMP had recommended to the European Commission to withdraw the MPOXX indication. We are currently taking the necessary regulatory steps to inform all relevant stakeholders, as well as implement the CHMP recommendation following its adoption by the European Commission.
Having said all that by way of background, TPOXX was developed as a treatment for smallpox to save lives and to serve as a critical countermeasure against smallpox. Smallpox is one of the world's most dangerous biothreats, and this antiviral is needed in the event of an outbreak. In contrast, the MPOXX trials measure tecovirimat's benefit using complete lesion resolution, an endpoint related to the immune activity in patients already progressing toward self-resolution. Stabilized patients suffering from smallpox have been and will continue to be SIGA Technologies, Inc.'s focus.
Jyoti Prakash: Thank you, this was quite helpful. And my next question is related to the dividend payout. You recently paid out the fifth consecutive annual special dividend. Now this is a sign of a strong balance sheet, but how comfortable are you returning this level of capital while maintaining sufficient liquidity through the potential gaps in government ordering, particularly given that the revenues tend to be lumpy?
Daniel J. Luckshire: Hi, Jyoti. Maybe as a starting point, just to point out that the 2026 dividend, as well as prior dividends, were declared and have been declared and paid with the understanding that we do have a business model that is subject to variability. This variability has been a consistent feature of SIGA Technologies, Inc.'s business model, so it is not really a new thing. We have been navigating this over the years. In assessing a potential dividend in 2026, we considered many factors, including our continuing focus on deploying capital to drive the greatest value for shareholders, as well as our substantial cash balance, which at March 31 was approximately $146 million.
When you take into account the dividend on a pro forma basis, the cash balance would still be over $100 million, and with no debt. So when you take all these things into account, as well as multiple other considerations, the company believes that we continue to be well positioned to navigate any near-term gaps in government ordering.
Jyoti Prakash: That is great, Dan. And you mentioned that your cash position remains strong even after the dividend payout. Now if we look ahead, what would be your key priorities for capital deployment? And we have asked this previously, but are you actively considering acquisitions or in-licensing opportunities?
Daniel J. Luckshire: Yes. As you mentioned, it has been a discussion point in the past. And the answer is yes, we continue to explore ways to expand the pipeline, either through acquisition or in-licensing. As we have highlighted on prior calls, we remain committed to deploying capital in ways that we believe will drive the greatest value. That could be through dividends, through acquisitions, through in-licensing, or through other means.
Jyoti Prakash: Thank you, that is very helpful. And I have one final question, and this relates to international markets. You have announced a large $13 million order from the Asia-Pacific, which will be delivered in Q2. And you also announced the recent licensing agreement with Hikma for the MENA region. Are you seeing a broader increase in stockpiling interest across all international markets, or is it restricted to any particular geographies? And just following on from that, on the Hikma agreement, can you provide a bit more color on the deal economics, and if it is structured similarly to your previous partnership with Meridian?
Diem Nguyen: Yes, I can take that. As we mentioned earlier in the call, we do expect to deliver approximately $13 million of oral TPOXX to an international customer in the second quarter. We remain engaged and active with other potential customers, and we will provide updates as additional orders occur in this region as well as others. It is not specific to a target region. In addition, with our conversations with Hikma, we are quite enthusiastic and excited about the opportunity, as we believe Hikma can help unlock demand across the MENA region, which was underrepresented for SIGA Technologies, Inc. before.
As noted in our prepared remarks, their strong regional presence and deep expertise navigating complex procurement processes make them a highly strategic and attractive partner to bring TPOXX to these markets. In short, from a deal construct perspective, we will supply finished product to Hikma, who will manage the customer relationships in the region. TPOXX will be sold at a price set forth in the agreement. SIGA Technologies, Inc. may also be entitled to additional payments under certain conditions. The financial terms of the agreement are confidential and will not be further disclosed.
Jyoti Prakash: Thank you, this is very helpful. No further questions from my side.
Operator: There are no further questions at this time. I will turn the call back over to Diem Nguyen.
Diem Nguyen: I would like to thank everyone for making the time to join us on today's call and for your ongoing interest in SIGA Technologies, Inc. We look forward to speaking to you again in our second quarter call.
Operator: Have a great evening. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
