Heidelberg Pharma AG · XETR:HPHA
Heidelberg Pharma — FY2021 Earnings Presentation
25 slides from Heidelberg Pharma's earnings presentation, Mar 24, 2022
Slide 1: ATACs: Unique New Mode of Action to Fight Cancer
ATACs: Unique New Mode of Action to Fight Cancer 24th March 2022 FY 2021 Financial Results & Business Update © Heidelberg Pharma AG
Slide 2: Safe Harbor
Safe Harbor Forward-looking statements This communication contains certain forward-looking statements, limitations of insurance, limitations of supplies, competition from other relating to the Company’s business, which can be identified by the use of biopharmaceutical, chemical and pharmaceutical co
Slide 3: Corporate Overview & Highlights
Corporate Overview & Highlights ATAC® Projects Update Financials Outlook © Heidelberg Pharma AG 3
Slide 4: Heidelberg Pharma Corporate Overview
Heidelberg Pharma Corporate Overview Developing new options to address major challenges in cancer therapy Our Company Our Mission Our Approach Listed as Heidelberg Pharma AG New option in cancer therapy with Inhibition of RNA Polymerase II Frankfurt Stock Exchange: HPHA a unique mode of action Amani
Slide 5: Highlights 2021 – Corporate Update
Highlights 2021 – Corporate Update Corporate Update Expansion of leadership team with wealth of experience in Financing secured clinical development • €15 m loan commitment in December 2020 and €30 m Dr. András Strassz financing commitment in March 2021 from main shareholder Chief Medical Officer di
Slide 6: Growing Pipeline
Growing Pipeline Program Target Indication Research Preclinic Clinic Partner ATAC® pipeline I II III HDP-101 BCMA Multiple myeloma (DLBCL/CLL) Huadong (Asia) HDP-102 CD37 NHL Huadong (Asia; option) HDP-103 PSMA Prostate cancer Huadong (Asia) HDP-104 n/a Undisclosed tumor indication Huadong (Asia; op
Slide 7: Highlights 2021/22 – Proprietary ATAC Programs
Highlights 2021/22 – Proprietary ATAC® Programs ATAC® Programs HDP-101 – first-in-human study with a completely new mode of action • IND/CTA approvals: FDA (US) & PEI (Germany) and initiation of study centers in US and Germany • First patient dosed (Feb 2022) Candidates HDP-102 and HDP-103 • Product
Slide 8: Highlights 2021/22 – ATAC Technology Collaborations
Highlights 2021/22 – ATAC® Technology Collaborations ATAC® Technology Collaborations MGTA-117: Depletion of hematopoietic stem and progenitor cells (targeted conditioning) • IND granted by FDA in September 2021 • Phase I/II clinical trial in patients with relapsed/refractory acute myeloid leukemia a
Slide 9: Highlights 2021/22 and Upcoming Milestones – Legacy Portfolio
Highlights 2021/22 and Upcoming Milestones – Legacy Portfolio Licensed Clinical Projects (Legacy Assets, Non-ATACs) ZIRCON Phase III study with imaging agent TLX250-CDx (89Zr-DFO-girentuximab) - Breakthrough Therapy Designation • Target enrolment of 252 kidney cancer patients reached in March 2022,
Slide 10: ATAC Projects Update
Corporate Overview & Highlights Financials Outlook © Heidelberg Pharma AG 10
Slide 11: Lead Program: HDP-101 in Multiple Myeloma
Lead Program: HDP-101 in Multiple Myeloma Multiple Myeloma (MM) HDP-101: Anti-BCMA-ATAC • 70,000 deaths annually • Preclinical validation in in-vitro and • Median survival ~47-110 months in-vivo models • Characterized by the proliferation of single clone of plasma cells derived from B-cells • Target
Slide 12: HDP-101-01 Clinical Trial in Multiple Myeloma
HDP-101-01 Clinical Trial in Multiple Myeloma Two-part, Open-label, Multicenter Phase I/IIa Study Clinical trial designed to determine safe dose and assess preliminary efficacy Phase I: Phase IIa: • Up to 36 patients with relapsed / refractory multiple myeloma • Up to 30 patients with RRMM (RRMM) •
Slide 13: HDP-101: Clinical Development Plan for Multiple Myeloma
HDP-101: Clinical Development Plan for Multiple Myeloma 2021 2022 2023 2024 2025 Expansion cohorts: Assess accelerated stratification approval option Registrational del(17p) BLA cohort IND FPI Dose escalation in MM patients RP2D no del(17p) First clinical safety data Additional indications / combina
Slide 14: HDP-101: Differentiated Profile Predicts Clinical Benefit
HDP-101: Differentiated Profile Predicts Clinical Benefit Unique preclinical features of HDP-101 Potential clinical benefit Efficacious against dormant tumor cells Longer PFS and MRD negativity Efficacious in ultra-low BCMA tumor cells Deeper responses and higher ORR Novel MoA to which all patients
Slide 15: Further ATAC Candidates and technology
Further ATAC® Candidates and technology HDP-102: Anti-CD37-ATAC New scientific data generated • CD37 is overexpressed on B-cell lymphoma cells • Preclinical data presented at AACR in April 2021: • Target indication: Non-Hodgkin lymphoma (NHL) • Evaluation of anti-CD37 ATAC in B-cell malignancies (HD
Slide 16: Financials
Corporate Overview & Highlights ATAC® Projects Update Outlook © Heidelberg Pharma AG 16
Slide 17: Profit and Loss 2021
Profit and Loss 2021 in € m Guidance 10/2021 FYR 2021 FYR 2020 Change Sales revenue and other income 2.0 – 2.5 2.3 9.6 -76% Operating expenses 26.0 – 28.5 27.9 27.9 0% Operating expenses Cost of sales 4.7 5.6 -16% 2% 17% 14% R&D costs 18.7 18.3 2% Administrative costs 4.0 3.6 11% €27.9m Other expens
Slide 18: Balance Sheet and Cash 2021
Balance Sheet and Cash 2021 Financing 2021 • €15 m shareholder loan in December 2020; €30 m commitment by dievini in March 2021 • €20 m gross proceeds from private placement with dievini and select institutional investors in June 2021; • Issue of 3.1 million new shares (10% of share capital) at €6.4
Slide 19: Outlook
Corporate Overview & Highlights ATAC® Projects Update Financials © Heidelberg Pharma AG 19
Slide 20: Guidance 2022
Guidance 2022 Financing Q1 2022 • €36 m commitment by dievini in February 2022, replacing former commitment • Cash reach is secured until mid-2023 based on current budget planning License and investment agreements with Huadong Medicine – which are still subject to various approvals – are not reflect
Slide 21: Strategic Partnership with Huadong
Strategic Partnership with Huadong Exclusive license agreement for the development and commercialization of ATAC® product candidates in Asia*, deal value of up to $930 m • Exclusive development and commercialization rights for HDP-101 • Deal is providing a strong partner in Asia* and HDP-103 • Upfro
Slide 22: Planned Equity Investment - Huadong to Become a Major Shareholder
Planned Equity Investment - Huadong to Become a Major Shareholder Investment agreement between Heidelberg Pharma, Huadong Medicine Investment Holding Rights issue… …using authorized (Huadong) and main shareholder dievini Hopp BioTech holding (dievini) capital • Investment of up to €105 m in Heidelbe
Slide 23: Upcoming Milestones and Initiatives
Upcoming Milestones and Initiatives Program Timing ATAC® pipeline HDP-101: Recruitment ongoing HDP-101: First safety data expected 2022 HDP-102 & HDP-103 on track to IND 2023 HDP-104 research ongoing ATAC® collaborations Magenta: Clinical data from Ph I/II trial with MGTA-117 2022 Sign additional li
Slide 24: Investment Summary
Investment Summary Heidelberg Pharma: A clinical-stage company with the goal of becoming a global ADC player Potential USP with our proprietary ATAC® technology: • disruptive first-in-humans mode of action provides high efficacy and potential for unique clinical advantages, including treatment of do
Slide 25: Contact Us
Contact Us Heidelberg Pharma AG IR/PR support Ticker data Gregor-Mendel-Str. 22 MC Services AG ISIN: DE000A11QVV0 68526 Ladenburg, Germany Katja Arnold (CIRO) Symbol: HPHA Tel.: +49 6203 1009-0 Tel.: +49 89 210 288-40 Reuters: HPHA.DE Fax: +49 6203 1009-19 Email: katja.arnold[at]mc-services.eu Bloom