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Biotest AG Interim / Quarterly Report 2024
66_rns_2024-11-14_bf989202-acac-4371-b06b-e99ace3cfb09.pdf
Interim / Quarterly Report
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$>$ BIOTEST GROUP
Nine Month 2024 Results, November, 2024
> BIOTEST GROUP
Biotest Group - Highlights Nine Month 2024
DEVELOPMENT PROJECTS - GENERAL OVERVIEW
Biotest Group - Highlights Q1 - Q3 2024
YIMMUGO ${ }^{\circledR}$
- Yimmugo ${ }^{\circledR}$ Approval by the U.S. Food and Drug Administration (FDA) in June 2024
- Successful FDA inspection of Biotest Next Level production plant in Dreieich, Germany
- Biotest AG and Kedrion Biopharma, Inc. have entered into a strategic partnership for the distribution and commercialization of the immunoglobulin therapy Yimmugo ${ }^{\circledR}$ in the USA
Yimmugo* - Registration and Launch
| 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|
| - Brand name Yimmugo* | - Start Production - Launch Germany |
- Launch Austria - BLA submission |
- Launch UK - BLA approval - MA Norway - MA Netherlands - MA Hungary - MA Irland |
- Launch USA |
Biotest Group - Highlights Q1-Q3 2024
FIBRINOGEN
- Submission for registrations already completed in Germany, Austria and Spain in Q3 2024
- Submission of US registrations for both Fibrinogen indications planned in Q4 2024
- Results of congenital and acquired Fibrinogen deficiency Phase III studies confirm high expectation regarding efficacy and safety
- Presentation of results at a scientific congress end of 2024
Biotest Group - Highlights Q1-Q3 2024
TRIMODULIN
- Two Phase III Trimodulin trials ongoing
- CAP Study: Interim Analyses planed according to patient recruitment, currently slow recruitment
- sCAP Study: ongoing, initiatives to support recriutment ongoing
Biotest Group - Highlights Q1-Q3 2024
PRODUCT DEVELOPMENT
- Cytotect ${ }^{\circledR}$ : Increased sales for Cytotect ${ }^{\circledR}$ in France, Spain and Italy. New marketing authorization in Thailand
- Pentaglobin ${ }^{\circledR}$ : Positive sales growth in various European and international markets, such as Germany, Colombia, Turkey and India
- Zutectra ${ }^{\circledR}$ : Initial sales generated Turkey and Taiwan
- Intratect ${ }^{\circledR}$ : Positive sales growth for Intratect in various regions
2 Biotest
From Nature for Life
BIOTEST GROUP
Biotest Next Level
Biotest Next Level - Successful FDA Inspection
- 13 June 2024: FDA approval of Yimmugo ${ }^{\circledR}$
- Approval for Biotest Next Level Manufacturing plant by Inspection and validation of quality systems, Yimmugo ${ }^{\circledR}$ manufacturing plant, compliance of the production process with the submitted dossier validated and verified
- Fibrinogen: 19 June 2024 successful GMP inspection by German Authority (HLfGP); Process Performance Qualification runs successfully completed. Marketing Authorisation Application and Biological License Application in preperation
- Albumin: Commissioning for capacity increase
Expansion of Plasma Collection Centres
Europe: 40 plasma collection centres
- 4 new centres in Germany in 2024
- 2 new centres in 2023 in Germany and in Hungary
- 7 new centres in 2022 in Czech Republic
Access to US Plasma
- Long-term supply contracts with Grifols and other third parties
> BIOTEST GROUP
Financials Q1 - Q3 2024
-
Sales
$(+4.5 \%)$
€ 500.3
million
Q1-Q3 2023
EBIT
€ 125.4
million
Q1-Q3 2024
Q1-Q3 2023
Q1-Q3 2024
EBITDA
$€ 152.0$
million
Biotest Group
Income Statement (€ million)
| Q1-Q3 $\mathbf{2 0 2 3}$ |
Q1-Q3 $\mathbf{2 0 2 4}$ |
Dev. in \% |
|
|---|---|---|---|
| Sales in regions | $\mathbf{5 0 0 . 3}$ | $\mathbf{5 2 2 . 7}$ | 4.5 |
| thereof: European Union | 195.6 | 204.6 | 4.6 |
| Rest of World | 169.3 | 209.8 | 23.9 |
| Stateless | 135.4 | 108.3 | -20.0 |
| COGs and operating expenses | -374.9 | -451.6 | -20.5 |
| Operating profit (EBIT) | $\mathbf{1 2 5 . 4}$ | $\mathbf{7 1 . 1}$ | -43.3 |
| Financial result, taxes | -37.0 | -41.2 | -11.4 |
| Earnings after tax (EAT) Biotest Group | $\mathbf{8 8 . 4}$ | $\mathbf{2 9 . 9}$ | $>-100$ |
Revenue Q1-Q3 2024
- Revenue growth of $+4.5 \%$ is mainly due to revenue generated by products (Yimmugo and Intratect) increased by $€ \mathbf{5 8 . 1}$ million vs. 2023
- Product revenues and toll manufacturing increased by $13.7 \%$ to $€ 414.4$ million
EBIT Reported and Adjusted (€ million)
| Q1-Q3 $\mathbf{2 0 2 3}$ |
Q1-Q3 $\mathbf{2 0 2 4}$ |
Dev. in \% |
|
|---|---|---|---|
| EBIT reported | $\mathbf{1 2 5 . 4}$ | $\mathbf{7 1 . 1}$ | -43.3 |
| Earnings from technology disclosure |
-108.9 | -84.2 | 22.7 |
| Earnings from development services |
-3.4 | -3.1 | 8.8 |
| Expenses for Biotest Next Level | 44.8 | 53.2 | 18.8 |
| Disposal gain from sale of five subsidiaries |
-23.1 | - | 100.0 |
| EBIT adjusted | $\mathbf{3 4 . 8}$ | $\mathbf{3 7 . 0}$ | 6.3 |
- Adjusted EBIT describes the operating performance of the Biotest Group excluding special effects.
- In order to ensure continuity and comparability, the expenses from the Biotest Next Level expansion project of $€ 53.2$ million (previous year: $€ 44.8$ million) are shown.
- Special effects in Q1-Q3 2024 also relate to income from the technology disclosure of $€ 84.2$ million, from development services of $€ 3.1$ million generated with Grifols, S.A
Balance Sheet as of 30 September 2024 (€ million)
Cash Flow from Operating Activities
| JANUARY - SEPTEMBER 2024 (€ MILLION) | Q1-Q3 2023 |
Q1-Q3 2024 |
|---|---|---|
| Operating CF before Changes in Working Capital | 130.4 | 80.8 |
| Cashflow from Changes in Working Capital | $-179.3$ | $-29.5$ |
| thereof: Changes Inventories | $-90.1$ | $-44.2$ |
| Changes Trade Receivables | $-104.1$ | 26.4 |
| Other Changes | 14.9 | $-11.7$ |
| Interest \& Tax expense | $-20.1$ | $-27.9$ |
| Cashflow from Operating Activities | $-69.0$ | 23.4 |
Guidance 2024
Revenue:
Increase in sales in the upper single-digit percentage range vs. 2023, incl. sales from the technology disclosure and development services for Grifols, S.A.
EBIT:
Operating result expected in the range of
€ 80 to 100 million for 2024.
Cash Flow:
Cash flow from operating activities in the negative mid doubledigit million range.
ROCE:
Expected ROCE in the range of 5-8\%.
Strategic Targets
- Responsible \& sustainable growth
- Growth through increased new capacity
- Increased patient access by new products and new markets
- Improved efficiency
- Extended partnership with Grifols and Kedrion
Financial Calendar 2024/ 2025
28 March 2025 Annual report 2024
Investor Relations
Dr. Monika Baumann (Buttkereit)
Tel.: +49-6103-801-4406
[email protected]
Public Relations
Dirk Neumüller
Tel.: +49-6103-801-269
[email protected]
2. Biotest
We look forward to your questions.
2. Biotest
Thank you for your attention.
A. Biotest
Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments.
The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
All comparative figures relate to the corresponding last year's period, unless stated otherwise.