AI assistant
Biotest AG Interim / Quarterly Report 2024
66_rns_2024-08-06_8db4e4f1-a16b-43ce-b2a6-d05f0fb41f8d.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
BIOTEST GROUP
Half Year 2024 Results, August 6, 2024
BIOTEST GROUP
Biotest Group - Highlights Half Year 2024
RESEARCH \& DEVELOPMENT
DEVELOPMENT PROJECTS - GENERAL OVERVIEW
PID = Primary Immune Deficiency; ITP = Idiopathic Thrombocytopenic Purpura; sCAP = severe community acquired pneumonia
Biotest Group - Highlights H1 2024
YIMMUGO ${ }^{\circledR}$
- Yimmugo ${ }^{\circledR}$ : FDA approval in the US in June 2024. Successful FDA inspection of Biotest Next Level production plant in Dreieich, Germany
- Biotest AG and Kedrion S.p.A entered into a strategic partnership for a long-term agreement for the distribution and commercialization of the immunoglobulin therapy Yimmugo ${ }^{\circledR}$ in the U.S.
Yimmugo* - Registration and Launch
| 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|
| - Brand name Yimmugo* | - Start Production - Launch Germany |
- Launch Austria - BLA submission |
- Launch UK - MA Norway - MA Netherlands - BLA approval - Launch volumes US |
- Launch USA |
Biotest Group - Highlights H1 2024
FIBRINOGEN
- Results of congenital and acquired Fibrinogen deficiency Phase III studies confirm high expectation regarding efficacy and safety
- Scientific Publication to be published within scientific congress end of 2024
- Preparation of EU and US registration for both Fibrinogen indications for end of 2024
Biotest Group - Highlights H1 2024
TRIMODULIN
- Two Phase III Trimodulin trials ongoing
- CAP Study: Interim Analyses planed according to patient recruitment
- sCAP Study: ongoing
- Qualification on BNL manucaturing site for Trimodulin ongoing
Biotest Group - Highlights H1 2024
PRODUCT DEVELOPMENT
- Cytotect ${ }^{\circledR}$ : Increased sales for Cytotect ${ }^{\circledR}$ in France, Spain, Saudi-Arabia and UK. New marketing authorization in Thailand
- Pentaglobin ${ }^{\circledR}$ : Positive sales growth in various European and international markets, such as Germany, Colombia, Vietnam and India
- Zutectra ${ }^{\circledR}$ : Initial sales generated Turkey, Taiwan
- Biotest Human Serum Albumin recorded significant revenue growth in H1 2024
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); Start of Process Performance Qualification
- Albumin: Commissioning for capacity increase
> BIOTEST GROUP
Financials H1 2024
HIGHLIGHTS
Sales
$(+35.1 \%)$
€ 275.3
million
H1 2023
Biotest Group
Income Statement (€ million)
| H1 2023 |
H1 2024 |
Dev. in \% |
|
|---|---|---|---|
| Sales in regions | 275.3 | 372.0 | 35.1 |
| thereof: European Union | 139.1 | 134.4 | $-3.4$ |
| Rest of World | 121.3 | 139.3 | 14.8 |
| Stateless | 14.9 | 98.3 | $>100$ |
| COGs and operating expenses | $-255.5$ | $-293.6$ | $-14.9$ |
| Operating profit (EBIT) | 19.8 | 78.4 | $>100$ |
| Financial result, taxes | $-18.1$ | $-39.3$ | $>-100$ |
| Earnings after tax (EAT) Biotest Group | 1.7 | 39.1 | $>100$ |
Revenue H1 2024
- Revenue growth of $+35.1 \%$ is mainly due to revenue generated from TTLA services for Grifols S.A., amounting to $€ 98.3$ million
- Product revenues and toll manufacturing increased by $4.8 \%$ to $€ 273.7$ million
- Specialty products (Cytotect and Pentaglobin) increased by $35 \%$ vs. H1 2023
- IVIG portfolio growing $14 \%$ vs. 2023 despite an observed price flexion on the main markets
- Sales via distribution partners and Grifols are growing
EBIT Reported and Adjusted (€ million)
| H1 2023 | H1 2024 | Dev. in \% |
|
|---|---|---|---|
| EBIT reported | $\mathbf{1 9 . 8}$ | $\mathbf{7 8 . 4}$ | $>100$ |
| Earnings from technology disclosure |
- | -84.2 | $>100$ |
| Earnings from development services |
-1.9 | -1.8 | -5.3 |
| Expenses for Biotest Next Level | 43.8 | 52.9 | 20.8 |
| Disposal gain from sale of five subsidiaries |
-23.1 | - | $>100$ |
| EBIT adjusted | $\mathbf{3 8 . 6}$ | $\mathbf{4 5 . 3}$ | 17.4 |
- 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 $€ 52.9$ million (previous year: $€ 43.8$ million) are shown.
- Special effects in H1 2024 also relate to income from the technology disclosure of $€ 84.2$ million, from development services of $€ 1.8$ million generated with Grifols, S.A
Balance Sheet as of 30 June 2024 (€ million)
Net debt as of 30 Jun 2024: $€ 532.6 \mathrm{~m}$
Equity ratio as of 30 Jun 2024: $39.0 \%$
Improved equity ratio of $39.0 \%$ from $35.4 \%$
Cash Flow from Operating Activities
| JANUARY - JUNE 2024 (€ MILLION) | H1 2023 |
H1 2024 |
|---|---|---|
| Operating CF before Changes in Working Capital | 18.5 | 102.5 |
| Cashflow from Changes in Working Capital | $-81.6$ | $-36.0$ |
| thereof: Changes Inventories | $-46.9$ | $-53.2$ |
| Changes Trade Receivables | $-32.8$ | 26.6 |
| Other Changes | $-1.9$ | $-9.4$ |
| Interest \& Tax expense | $-11.7$ | $-19.7$ |
| Cashflow from Operating Activities | $-74.8$ | 46.8 |
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:
Positive cash flow from operating activities above the previous year's level.
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
Financial Calendar 2024
05 Nov 2024 Q1-Q3 Report
Investor Relations
Dr. Monika Baumann (Buttkereit)
Tel.: +49-6103-801-4406
[email protected]
Public Relations
Dirk Neumüller
Tel.: +49-6103-801-269
[email protected]
$\Delta$ Biotest
From Nature for Life
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.