On October 17, 2024 Hansa Biopharma Reports Third Quarter and Interim January – September 2024 Financial Results (Press release, Hansa Biopharma, OCT 17, 2024, View Source;september-2024-financial-results-302278809.html [SID1234647258]).
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Søren Tulstrup, President and CEO, Hansa Biopharma said, "The third quarter of 2024 marks the highest ever IDEFIRIX sales performance to date, resulting in four consecutive quarters of strong sales performance. The launch of IDEFIRIX in Europe continues to advance with adoption in international organ allocation systems and an increase in new and repeat utilization in leading transplant clinics. Equally, we see strong momentum in our clinical development programs in autoimmune, gene therapy and transplantation. Enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM has reached 86%. In the Post Authorization Efficacy and Safety (PAES) study in kidney transplant enrolment has reached 78%. Finally, just after quarter end, we communicated positive results from the 12-month analysis of NICE-01, demonstrating that HNSA-5487 can robustly and very rapidly reduce IgG levels, has clear redosing potential, and a favorable safety and tolerability profile. Initial clinical development will focus on neuromyelitis optica (NMO), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), and myasthenia gravis (MG)."
Financial Performance
The Company recorded total revenue of 78.4 MSEK. Of this, 69.5 MSEK is attributed to IDEFIRIX sales, marking the highest ever quarterly in-market sales. This excludes the impact of a 29.7 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. Of the total provision only 4.9 MSEK was related to Q3 sales. Net of the provision, Q3 2024 IDEFIRIX sales were 39.8 MSEK and total year to date IDEFIRIX sales were 114.5 MSEK. Previously, the Company recorded a provision of 19.9 MSEK in Q2 2024. Of this, 2.0 MSEK was related to sales in Q2 2024. Of the total provision taken in Q2 and Q3 2024, 42.7 MSEK relates to previous periods since launch in 2020.
Pipeline Progress
Progress across the pipeline included the strong momentum in enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM (86%), and in the Post Authorization Efficacy and Safety (PAES) study in kidney transplantation (78%). Further efficacy data from the 15-HMedIdes-09 Phase 2 trial in Guillain-Barré Syndrome (GBS) is scheduled to read out by the end of 2024. The ConfIdeS trial continues to progress following completed randomization in May and data from the study is expected to provide the basis for a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in the second half of 2025. On 7 October 2024, Hansa announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential.
Financial Summary
MSEK, unless otherwise stated – unaudited
Q3 2024
Q3 2023
9M 2024
9M 2023
Total Revenue
78.4
22.8
188.6
83.7
Provision1
(29.7)
–
(49.6)
–
Net revenue after provision
48.7
22.8
139.0
83.7
SG&A expenses
(75.8)
(111.7)
(255.3)
(344.5)
R&D expenses
(79.6)
(95.6)
(274.3)
(303.1)
Loss from operations
(116.9)
(202.2)
(463.7)
(613.0)
Loss for the period
(103.8)
(250.7)
(530.3)
(707.3)
Net cash used in operations
(148.8)
(193.8)
(527.1)
(582.7)
Cash and short-term investments
553.5
908.2
553.5
908.2
EPS before and after dilution (SEK)
(1.53)
(4.78)
(8.67)
(13.49)
Number of outstanding shares
67,814,241
52,671,796
67,814,241
52,671,796
Weighted average number of shares before and after dilution
67,814,241
52,597,502
61,162,934
52,495,705
No of employees at the end of the period
135
168
135
168
1 Product sales in the third quarter 2024 totaled 69.5 MSEK. Sales were offset by a provision totaling 29.7 MSEK for potential credits associated with volume discounts and rebates. Year to date 2024 IDEFIRIX product sales totaled 164.1 MSEK and were offset by a provision totaling 49.6 MSEK. Net of the provision, year-to-date 2024 product sales totaled 114.5 MSEK.
Conference Call Details
Hansa Biopharma will host a telephone conference today Thursday, October 17, 2024, at 14:00 CET / 8:00 am ET.
The event will be hosted by Søren Tulstrup, President and CEO, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It 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.
To participate in the telephone conference, please use the dial-in details provided below:
Participant Dial In (Toll Free): 1-877-270-2148
Participant International Dial In: 1-412-902-6510
*Please ask to be joined into the Hansa Biopharma call