LUND, Sweden, July 18, 2024 /PRNewswire/ -- Hansa Biopharma today announced its first half and second quarter 2024 financial results and business update.

Søren Tulstrup, President and CEO, Hansa Biopharma said: "For the third consecutive quarter, Hansa Biopharma delivered solid IDEFIRIX^® sales performance driven by continued utilization of IDEFIRIX in key transplant centers across all major European markets. Additionally, we continued to progress key trials across the pipeline. Notably, we completed randomization of all patients in ConfIdeS, our pivotal Phase 3 US trial in kidney transplantation, and look forward to communicating data in the second half of 2025 with an expected Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA). Also, our Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease and the European Post Authorization Efficacy Study (PAES) in kidney transplant have both increased enrollment and remain on track. Looking ahead, the Company has several important milestones in the second half, including further analysis of data from the Phase 1 study of HNSA-5487, the Company's second-generation IgG cleaving enzyme designed to be re-dosed."

Financial Performance

The Company delivered strong financial performance for the third consecutive quarter with total revenue of 54.2 MSEK. Of this, 47.1 MSEK is attributed to IDEFIRIX sales. This excludes the impact of an approximate 20 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. After accounting for this provision, total IDEFIRIX product sales were 27.2 MSEK.

Sales performance was primarily driven by continued expansion of IDEFIRIX in key European markets. To date, the Company has secured reimbursement in 14 European markets.

In Q2 2024, the Company completed a directed share issue, raising gross proceeds of 372 MSEK (US $34.6M) primarily from high-quality international healthcare specialist investors.

Pipeline Progress

Progress across the pipeline included the completed randomization in the ConfIdeS pivotal Phase 3 US trial in kidney transplantation, further enrollment in the European Post Approval Efficacy Study in kidney transplantation (70 percent) with expected completion by 2025, and continued enrollment (70 percent) in the GOOD-IDES-12 Phase 3 trial in anti-GBM disease with data readout in 2025.

Financial Summary


     
              MSEK, unless otherwise stated - unaudited                                                                                                                                                          Q2 2024                       Q2 2023                       H1 2024                       H1 2023



     Revenue                                                                                                                                                                                                          34.3                           36.7                           90.3                           60.8



     - thereof: Product sales(1)(Q2 product sales 47.1 MSEK less provision 19.9 MSEK = 27.2 MSEK)                                                                                                                     27.2                           29.6                           74.7                           43.9



     SG&A expenses                                                                                                                                                                                                  (88.2)                       (129.5)                       (179.5)                       (232.8)



     R&D expenses                                                                                                                                                                                                   (91.7)                       (114.7)                       (194.6)                       (207.5)



     Loss from operations                                                                                                                                                                                          (187.4)                       (228.5)                       (346.8)                       (410.8)



     Loss for the period                                                                                                                                                                                           (207.9)                       (251.2)                       (426.5)                       (456.6)



     Net cash used in operations                                                                                                                                                                                   (189.2)                       (181.9)                       (378.3)                       (388.9)



     Cash and short-term investments                                                                                                                                                                                 705.0                        1,102.5                          705.0                        1,102.5



     EPS before and after dilution (SEK)                                                                                                                                                                            (3.30)                        (4.79)                        (7.38)                        (8.71)



     Number of outstanding shares                                                                                                                                                                               67,814,241                     52,443,962                     67,814,241                     52,443,962



     Weighted average number of shares before and after dilution                                                                                                                                                62,929,675                     52,443,962                     57,800,736                     52,443,962



     No of employees at the end of the period                                                                                                                                                                          146                            162                            146                            162


                 (1) Product sales in the second quarter 2024 totaled 47.1 MSEK. Sales were offset by a provision totalling 19.9 MSEK for potential credits associated with volume discounts and potential refunds. First half 2024 product sales totaled 94.6 MSEK and were offset by the provision totaling 19.9 MSEK. Net of the provision, first half product
                  sales totaled 74.7 MSEK.

Conference Call Details

Hansa Biopharma will host a telephone conference today Thursday, July 18, 2024, at 14:00 CET / 8:00 am EST.

The event will be hosted by Søren Tulstrup, President and CEO, Matthew Shaulis, Chief Commercial Officer and US President, Evan Ballantyne, Chief Financial Officer, and Hitto Kaufmann, Chief R&D Officer. The presentation will be held in English.

Slides used in the presentation will be live on the company website during the call under "Events & Presentations" and will also be made available online after the call. Link to presentation

To participate in the telephone conference, please use the dial-in details provided below:

Sweden: +46 812 410 952

United Kingdom: +44 203 769 6819

United States: +1 646 787 0157

Participant access code: 765135

The webcast will be available on https://hansabiopharma.eventcdn.net/events/half-year-january-june-2024

For the full financial calendar and list of events in 2024 please visit https://www.hansabiopharma.com/investors/calendar/

This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.

For more information:

Evan Ballantyne, CFO
E: ir@hansabiopharma.com

Stephanie Kenney, VP Global Corporate Affairs
E: media@hansabiopharma.com

About Hansa Biopharma

Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at hansabiopharma.com.

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The following files are available for download:


     
     https://mb.cision.com/Main/1219/4016231/2919974.pdf 20240718 HNSA -Q2 2024 Quarterly Report
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