Hansa Biopharma AB (publ)

All participants will be in listen-only mode. Since you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad, and to withdraw your question, please press star then two. Please note, today's event is being recorded. I would now like to turn the conference over to Renee Aguiar-Lucander, Chief Executive Officer. Please go ahead.

Thank you. Good afternoon and good morning, everyone, and welcome to the HANSA Biopharma Conference Call to review Q2 and half-year results for 2025. I'm Renee Aguirre-Lukander, CEO for HANSA Biopharma, and joining me today is Evan Ballantyne, Chief Financial Officer, Ito Kauffman, Chief Scientific and Technology Officer, and Maria Tarnson, Chief Operating Officer and President of the US. Please turn to slide two. Please allow me to draw your attention to the fact that we will be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three. So this, today we'll discuss the progress we've made in the first half of 2025 and review the quarterly performance. I'll also share my reflections and insights based on my first few months in the role. The presentation should take roughly 50, 20 minutes, 15 to 20 minutes after which there'll be an opportunity to ask questions during a Q&A session. If you can please turn to slide four for the significant achievements in the first half. In the first half of 2025, the company achieved several notable achievements. Of note, in Q2, we stabilized the business through a directed share issue and the restructuring of existing debts held by NovaQuest. Together, these actions ensure a cash runway into Q2 2026, and the opportunity to read out the two phase three trials, the CONFIDUS-US trial in kidney transplantation and the GUDIDIS-09 trial in anti-GBN, both scheduled for readout later this year. Additionally, we further bolstered the executive leadership team with the addition of Maria Tornson, CEO and President of the US, and Dr. Richard Philipson, Chief Medical Officer, who just joined us this week. In Q2, the company significantly increased sales revenues, as compared to previous year. We continue to see an increase in transplant clinics with initial and repeat usage of Idoferix, and we're encouraged about the number of regional and local clinical consensus on the appropriate use of Idoferix as desensitization treatment for highly sensitized patients. Additionally, in the first half of the year, we completed enrollment of the phase three post-authorization efficacy and safety, or PAES, study in kidney transplantation. We expect the data readout for that child to occur in the middle of 2026. The 15-age metal S09 phase two study in Guillain-Barre syndrome delivered positive results for amlifidase. This study was presented at a leading medical congress in Q2, and we look forward to following up with publishing the data during 2026. Please turn to page five. As mentioned, the company posted solid financial performance in the first half of the year. Idaferic sales revenue for Q2 was 47.9 million Swedish crowns, representing a 76% increase when compared to Q2 2024. Idaferic sales revenue for the first half of 2025 amounted to 113.5 million Swedish crowns, representing a 52% increase in Idaferic sales revenues. as compared to the same period last year, and around 80% of full-year product sales in 2024. As a consequence, the company's total revenue in the first half of 2025 represents a 27% increase as compared to the first half of 2024. So it is important to note that full-year 2024 interferix product sales were 140 million sec, and we believe despite continued market volatility, and quarterly variability that we're well positioned to significantly exceed this in 2025. Please turn to 2026, to slide six. So, as mentioned, there were two key financial catalysts for the company in Q2. The first was a successful capital raise of 232 million SEC to support key data readouts in the second half of 2025. including Confidus in kidney transplantation and Godida-02 in anti-GBM. Additionally, the company restructured the existing debt agreement with NovaQuest. The original agreement, which was set in July of 2022, has been amended to offset $14.8 million of outstanding debt to new shares or equity for NovaQuest. The remaining debt will be paid in fixed cash payments in June 2027-2028. and in 2029. A true up payment of $14.9 million is also due either in cash or in equity at the discretion of HANSA in January, 2026. Please turn to site seven for a brief overview of operational and strategic progress. So today it's been almost three months since I joined HANSA And during this time, I focused on reducing the annual burn rate to ensure a sustainable operating base for the company, and also worked to simplify and clarify reporting lines to enhance transparency, accountability, and speed of decision-making. I can now report that the restructuring process has been completed, and we expect that annual savings will exceed the previous estimates to amount to approximately 60 million SEC on an annual basis. We're obviously sad to see many extremely experienced colleagues leave us at this juncture, but the challenging and extremely volatile macro environment has, as you know, resulted in biotech companies taking a hard look at their cost basis, and we've taken that responsibility very seriously as reflected by the rapid action. In conjunction with these actions, however, we will invest in systems and processes, market research and analytics to support productivity and efficacy across operational activities, as well as select key U.S. market-related competencies and expertise to support our pre-commercial activities in the U.S. At this stage, I'm very happy with where the organization stands with regards to complementary expertise we've been able to attract and add to the highly experienced staff which Hansa already has in place. I believe that we will, at the end of the year, have an extremely strong, experienced, and aligned team to execute on our strategic goals. On this basis, We look forward to the upcoming catalyst in the second half of 2025, which I believe will put the organization in a position to truly leverage these strategic initiatives. I'd now like to turn it over to Maria Thunsen, who joined the company in Q2 as Chief Operating Officer and President of the US.

Thank you very much, Renée. I am very excited to join HANSA at an important time for the company. I've spent the last several weeks assessing our priorities and current preparation for several key milestones in the second half of the year. In a few minutes, I'll talk about the opportunities we have in the market. But first, I'd like to provide an update on the current European commercialization of Adiferix. Please turn to slide nine. In Q2 2025, we saw an increase in the overall number of centers using Adiferix, You may recall that last quarter, the PAES trial completed enrollment. And following this, 65% of these participating trial centers have now transitioned to commercial utilization. This affirms the fact that having both clinical experience and protocols in place to treat these highly sensitized kidney transplant patients is key to ibuprofen utilization. We also continue to see an increase in the total number of centers with repeat utilization. 60% of centers have had more than one positive clinical experience with Idiferix. This is good news, as it ensures that even more highly sensitized kidney transplant patients are gaining access to Idiferix and receiving a life-changing organ transplant. As mentioned in previous quarterly reports, the access to organs continue to fluctuate based on country and regional organ allocation system. Earlier in the year, Germany decided to pause the uro-transplant prioritization program for highly sensitized kidney transplant patients. This is a program which is active in seven other European countries. And while German physicians can use Idesirix through the standard allocation system, This lack of this prioritized program impacted Q2 revenues from Germany. We expect this to continue to have a negative impact over the near term. However, we are working with clinical, patient, and public health communities to understand the potential impact on commercialization in Germany over the longer term. Earlier in the quarter, additional consensus guidelines were published in the journal Transplant. This consensus from Belgium marks the ninth country with guidelines supporting the use of Idesperix as a desensitization strategy and reinforcing its potential to be the standard of care in kidney transplantation for highly sensitized patients. Finally, in Q2, we secured access in two additional markets, Australia and Switzerland. Idesperix is now reimbursed in a total of 20 countries, including the five largest European markets. Please turn to slide 10. I thought it was worth sharing the learnings from the European market and how the progress we have made here is helping us prioritize activities as we plan for entry into the U.S. market. As you may recall, there are 170,000 people on the kidney transplant wait list in Europe and in the U.S. Of that, approximately 25,000 have a CPRA above 98%. and are considered highly sensitized. And more than 5,000 have a CPRA over 99.9%. Without national prioritization programs and access to a desensitizing treatment, these highly sensitized patients have a very low chance to receive a kidney transplant. Idatherics therefore represents significant opportunity to transform kidney transplantation. Through commercialization of idatherics in Europe, we have gained several important learnings, which will help us as we prepare to enter the U.S. market. Organ allocation systems can be complex and vary between countries, and having local guidelines and centers that are clinically ready to use iretherics is critical for success. However, we need to remember that we will enter the U.S. market with access to significantly more clinical data and experience, compared to when we launched in Europe a few years ago. In addition to engaging with clinicians, we also need to establish an account approach to commercialization to ensure that the multidisciplinary team is educated on these anticipation and treatment guidelines. We will also focus on establishing a strong market access team to build relationships with the payer community and secure access for patients. Additionally, we are engaging with patient advocacy groups and policymakers to elevate the discussion on the unmet needs and changing the standard of care for highly sensitized patients. We are very excited and positive with regards to potential launch into the U.S. market, assuming approval, as we will have substantial multi-center clinical data from the Phase III study in the U.S., several high-volume, high-quality transplant centers, as well as the readout of a PAES study from Europe in mid-2026 involving 50 patients. In addition to these substantial data sets, there is also significant real-world data from Europe, which we believe will be supportive for adoption of this groundbreaking and innovative approach. I will now turn it over to Hito to cover off on the progress we have made with the pipelines.