Heidelberg Pharma AG · XETR:HPHA
Heidelberg Pharma — FY2023 Earnings Presentation
21 slides from Heidelberg Pharma's earnings presentation, Mar 25, 2024
Slide 1: ADCs: Unique Mode of Action to Fight Cancer
ADCs: Unique Mode of Action to Fight Cancer 25th March 2024 FY 2023 Financial Results & Business Update © Heidelberg Pharma AG
Slide 2: Safe harbor
Safe harbor Forward looking statements This communication contains certain forward-looking statements, relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or sim
Slide 3: Heidelberg Pharma at a glance
Heidelberg Pharma at a glance Differentiated ADC Technologies Strong IP • In Plug & Play mode • Several IP families • 2 years from target to IND • Monopoly in the Amanitin/MoA space GMP Manufacturing Partnerships • Fully synthetic process for Amanitin • Huadong: China-focused • 5 GMP batches complet
Slide 4: Our mission is the development of novel drugs for targeted cancer treatment
Our mission is the development of novel drugs for targeted and highly effective cancer treatment based on our ADC technologies © Heidelberg Pharma AG 4
Slide 5: Highlights – Corporate update
Highlights – Corporate update Executive Management Board expanded • Walter Miller was appointed CFO in May 2023 • Professor Andreas Pahl followed Dr. Jan Schmidt-Brand as CEO as of February 2024 Emergence Transaction • Minority shareholding in Emergence was sold to Eli Lilly for USD 7 million in Jun
Slide 6: Highlights 2023 – Expanded ADC technologies
Highlights 2023 – Expanded ADC technologies Developing an ADC toolbox and clinical product pipeline to overcome tumor resistance across cancer types Toolbox of proprietary payloads ATAC Technology TOPO1 Technology Immune-modulation RNA-Polymerase II Inhibitor Topoisomerase I Inhibitor Technology Ama
Slide 7: ATAC pipeline
Growing pipeline of proprietary and partnered programs Product Target Indication Research Preclinic Phase I Phase II Phase III Partner HDP-101 BCMA Multiple Myeloma Huadong (China+*) ATAC pipeline HDP-102 CD37 NHL (DLBCL/CLL) Huadong (option China+) HDP-103 PSMA Prostate cancer Huadong (China+) HDP-
Slide 8: R&D Update
R&D Update © Heidelberg Pharma AG 88
Slide 9: HDP-101 Phase I/II study in Multiple Myeloma patients
HDP-101 Phase I/II study in Multiple Myeloma patients Multiple Myeloma (MM) is a type of blood cancer • that develops from plasma cells in the bone marrow and can affect more than one part of the body • In myeloma, the bone marrow makes lots of abnormal (cancerous) plasma cells. • Worldwide incidenc
Slide 10: Dose scheme adaptation
Dose scheme adaptation Dose escalation continues with amended dosing scheme in Cohort 6 Starting from cohort 6, cohort will have 3 arms: • Arm A: single dose of HDP-101 (after premedication) on day 1 of each 21-day cycle • Arm B: split dose of HDP-101 on days 1, 8, and 15 of each cycle (weekly dosin
Slide 11: ADC candidate with new payload: HDP-201
ADC candidate with new payload: HDP-201 HDP-201: anti-GCC ATAC Exatecan - Camptothecin • New payload: Exatecan (Topoisomerase Inhibitor I) • Guanylyl cyclase C (GCC) is a transmembrane receptor protein (GUCY2C) for regulation of intestinal electrolyte homeostasis • (Over-) Expressed in >95% of color
Slide 12: Legacy portfolio: Partner Telix - Rolling BLA submission for Zircaix
Legacy portfolio: Partner Telix - Rolling BLA submission for ZircaixTM ongoing Pivotal Phase III ZIRCON reported positive topline results with imaging agent TLX250-CDx in November 2022 Accurate diagnosis of clear cell renal cell carcinoma (ccRCC) with TLX250-CDx (89Zr-DFO-girentuximab) now ZircaixTM
Slide 13: Financials
Financials © Heidelberg Pharma AG 13 13
Slide 14: Profit and loss 2023
Profit and loss 2023 in € m Guidance 2023 FYR 2023 FYR 2022 Change Sales revenue and other income 7.0 – 10.0 16.8 19.9 -15% Operating expenses 37.0 – 41.0 38.0 37.0 -3% Operating expenses Cost of sales 3.3 4.7 -30% 4% 8% 14% R&D costs 28.1 26.4 6% Administrative costs 5.2 4.8 9% €38.0m Other expense
Slide 15: Balance Sheet and Cash as of November 2023
Balance Sheet and Cash as of November 2023 Financings activities in 2023 • Cash inflow of €6.8 million due to the sale of the minority interest in Emergence • Partial repayment of the shareholder loan to dievini in the amount of €10 million (remaining loan outstanding €5 million) Assets (€ m) 30.11.
Slide 16: Royalty purchase agreement with HealthCare Royalty
Royalty purchase agreement with HealthCare Royalty Partial monetization of royalty stream for ZircaixTM (TLX250-CDx) in the field of diagnostic use Key terms of the agreement between Heidelberg Pharma and HealthCare Royalty: • USD 25 million upfront payment at closing, no repayment obligation in cas
Slide 17: Outlook
Outlook © Heidelberg Pharma AG 17 17
Slide 18: Guidance 2024
Guidance 2024 Guidance as of today (without impact of royalty purchase agreement) in € m FYR 2023 Guidance 2024 Sales revenue and other income 16.8 11.0 – 15.0 Operating expenses 38.0 36.0 – 40.0 Operating result (EBIT) (21.2) (23.5) – (27.5) Funds required 37.9 28.0 – 32.0 Funds required per month
Slide 19: Next steps proprietary ADC pipeline - High priority and focus on HDP-101
Next steps proprietary ADC pipeline - High priority and focus on HDP-101 to advance validation HDP-101 HDP-103 Phase I/IIa study in RRMM in USA and Europe PSMA-ATAC for prostate cancer • Adapted study design with dose optimization • Completion of preclinical and toxicology studies • Dose escalation
Slide 20: Our upcoming catalysts to become a leading global ADC player
Our upcoming catalysts to become a leading global ADC player Multiple inflection points with potential to increase company valuation significantly 2026/2027 End of 2025 Q3-4/2025 End of 2024 Q3/2024 HDP-201 CTA Approval HDP-102 RP2D Q2-3/2024 HDP-103 CTA Approval HDP-103 RP2D HDP-101 RP2D HDP-102 Fi
Slide 21: Thank you!
Heidelberg Pharma AG Ladenburg, Germany Thank you! Tel.: +49 6203 1009 0 investors@hdpharma.com www.heidelberg-pharma.com © Heidelberg Pharma AG 21