2024-02-02 14:30:04 ET
Hansa Biopharma AB (publ) (HNSBF)
Q4 2023 Earnings Conference Call
February 02, 2024 8:00 AM ET
Company Participants
Søren Tulstrup – Chief Executive Officer
Matt Shaulis – Chief Commercial Officer and U.S. President
Hitto Kaufmann – Chief Scientific Officer
Donato Spota – Chief Financial Officer
Conference Call Participants
Johan Unnerus – Redeye
Gonzalo Artiach – ABG Sundal Collier
Dominic Rose – Intron Health
Presentation
Operator
Hi, everyone, and welcome to the Hansa Biopharma Conference Call covering the Fourth Quarter and Full Year 2023 Earnings Results. Today's call is being recorded. For the first part of this call, all participants will be in a listen-only mode. Afterwards, there'll be a question-and-answer session. [Operator Instructions] Speakers, please begin.
Søren Tulstrup
Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review year-end results for 2023. I'm Søren Tulstrup, CEO of Hansa Biopharma. Joining me today is our Chief Commercial Officer and U.S. President, Matt Shaulis; our Chief Financial Officer, Donato Spota; and our Chief Scientific Officer, Hitto Kaufmann, who joined Hansa in December of last year. We're thrilled to welcome Hitto to the Hansa team at this pivotal time. With over 20 years of experience in research, development and advancement of science in both large pharma and small biotech organizations, Hitto is poised to lead the development of our scientific platform and advancement of our exciting pipeline of drug candidates. Hansa's Head of Investor Relations, Klaus Sindahl, is also with us.
Today, we'll discuss the progress we made during the last quarter of 2023 and review our near-term milestones. The presentation should take roughly 20 minutes, after which there will be an opportunity to ask questions during the Q&A session. Now please turn to Slide 2. 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 3, and an overview of Q4 highlights.
The fourth quarter of 2023 was a very eventful period for Hansa with strong commercial performance and continued solid progress across our pipeline development activities. In kidney transplantation, we continue to see good commercial progress in Europe as measured against our key launch metrics, including the implementation of treatment guidelines in both Italy and Germany, and continued growth in the number of clinics with desensitization protocols in place. During the fourth quarter, we saw strong revenue generation with total revenue ending at SEK50 million for the quarter, including SEK43 million in product sales, which was supported by growth in key new markets such as the U.K., Germany and Spain.
In the U.S., we continue to enroll patients in the Phase 3 ConfIdeS trial in kidney transplantation to accelerate randomization with the goal of completing randomization in mid-2024, and a BLA submission in 2025 after a 12-month follow-up on kidney function measured through eGFR. In October of 2023, we announced positive data from our five-year follow-up study, confirming that patient and graft survival outcomes in highly sensitized patients, desensitized using Idefirix continue to mirror what's seen in the broader transplant base. The data also demonstrated graft survival of 82%, which is consistent with the outcome seen at three years post transplant.
Outside our core markets in Europe and the U.S., we continue to expand access to imlifidase for highly sensitized kidney transplant patients. In the beginning of this year, we announced a new commercial partnership with NewBridge Pharmaceuticals covering the Middle East and North Africa, also known as the MENA region. Matt will discuss the commercial progress in more detail during his section of the call. In early December 2023, Hansa announced plans to restructure the organization to better align with and focus on key clinical development and commercial priorities. The restructuring will result in approximately 20% to 25% reduction in the current workforce and translate into approximately SEK75 million to SEK85 million in annual savings when fully implemented....
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Hansa Biopharma AB (publ) (HNSBF) Q4 2023 Earnings Call Transcript