Release Date: July 18, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Hansa Biopharma AB (FRA:24H, Financial) reported its third consecutive quarter of solid sales, with total revenue of SEK54.2 million, driven primarily by IDEFIRIX sales.
- The company secured its first commercial sales in Italy and achieved reimbursement status in key regions, expanding its market presence.
- The pivotal Phase 3 US trial for kidney transplantation, ConfIdeS, has been fully randomized, marking a significant milestone.
- Hansa Biopharma AB (FRA:24H) is progressing well with its post-authorization efficacy study in Europe, which could further support the adoption of IDEFIRIX.
- The company is advancing several trials in autoimmune diseases, with promising progress in Phase 3 anti-GBM disease and Phase 2 Guillain-Barre syndrome trials.
Negative Points
- The company faced a significant provision of SEK19.9 million associated with cumulative sales since the launch of IDEFIRIX in Europe, impacting revenue.
- SG&A expenses totaled SEK88 million in Q2 2024, including a restructuring reserve of approximately SEK3.5 million.
- R&D expenses for the second quarter of 2024 were SEK92 million, including a restructuring reserve of SEK6.6 million.
- The operating loss for the quarter was SEK187 million, driven by lower SG&A and R&D expenses but offset by higher cost of goods sold.
- The gross margin was negatively impacted by manufacturing costs, with three large batches of drug substance produced in Q2, increasing the cost of goods sold.
Q & A Highlights
Q: Can you comment on the sales development in Q2 and the post-approval study's patient recruitment?
A: The post-approval efficacy study is progressing, with a few additional patients added last quarter. We are on track to complete the study by the end of 2025. The study's caps will convert into commercial use of IDEFIRIX, benefiting future sales. (Soeren Tulstrup, CEO)
Q: When will the first indication for HNSA-5487 be announced, and will it come with the data announcement?
A: Once we get the full data set from the healthy volunteer study in the second half of this year, we will assess and chart the path forward, including indication selection. The decision on whether to communicate the path forward with the data or subsequently will be made then. (Soeren Tulstrup, CEO)
Q: Why did the Sarepta trial results move into 2025, and why is 12 months of follow-up needed for HNSA-5487?
A: Sarepta guided that data will be available in 2025 due to a protocol amendment. For HNSA-5487, we need 12 months of follow-up to assess the ability for short interval redosing and to monitor the development of anti-drug antibodies and IgG levels over time. (Soeren Tulstrup, CEO; Hitto Kaufmann, Chief R&D Officer)
Q: How do FcRn inhibitors and non-FcRn integrators compare to your enzyme in terms of indications?
A: FcRn inhibitors and biodegraders are more complementary to our enzyme, which has a unique profile in knocking down IgG completely and immediately. Our enzyme could be ideal at the onset of chronic autoimmune diseases during crises and flares. (Soeren Tulstrup, CEO; Hitto Kaufmann, Chief R&D Officer)
Q: Can you explain the adjustment to product sales and if it will be a regular occurrence?
A: Establishing a provision is an exercise in estimation and judgment. We monitor this quarterly and adjust as negotiations with European authorities progress. Once final prices are set, we won't need to make these provisions anymore. (Evan Ballantyne, CFO)
Q: What will drive IDEFIRIX sales growth in the second half of the year?
A: Growth will be driven by new centers coming online in countries like Italy and Spain, continued progress in Germany and France, and additional opportunities in the UK. Repeat usage across Europe will also contribute to growth. (Soeren Tulstrup, CEO; Matthew Shaulis, Chief Commercial Officer)
Q: Can you comment on the gross margin in Q2 and expectations for the coming quarters?
A: The Q2 gross margin was negatively impacted by manufacturing three large batches of drug substance. Excluding this, the gross margin would have been close to 70%. We expect the gross margin to improve in the next two quarters as we won't need to manufacture additional batches. (Evan Ballantyne, CFO)
Q: How will the cash position take you into 2026, and what will drive the reduced burn rate?
A: The reduced burn rate will come from both cost savings and top-line growth. We expect sales to increase in 2025 compared to 2024, and the full impact of restructuring activities will be realized in the third and fourth quarters of 2024 and into 2025. (Evan Ballantyne, CFO)
Q: What will the FDA require for full approval of IDEFIRIX in the US after accelerated approval?
A: We will need to run a confirmatory trial to get full approval. The specifics of this trial will be subject to alignment with the FDA. (Soeren Tulstrup, CEO)
Q: How will the US commercial launch of IDEFIRIX be targeted?
A: The initial focus will be on the 23 centers involved in the ConfIdeS study, as they will be familiar with identifying appropriate patients and incorporating IDEFIRIX into their treatment protocols. We will also target 50 to 70 centers with the necessary infrastructure for complex immunologic transplantation procedures. (Matthew Shaulis, Chief Commercial Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
