Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — FY2020 Earnings Presentation
28 slides from Heidelberg Pharma's earnings presentation, Mar 25, 2021
Slide 1: ATACs: a Unique New Mode of Action to Fight Cancer
ATACs: a Unique New Mode of Action to Fight Cancer March 25, 2021 FY 2020 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 Proprietary ATAC projects Update Partnered projects Update Financials & Financing Outlook © Heidelberg Pharma AG 3
Slide 4: Heidelberg Pharma at a Glance
Heidelberg Pharma at a Glance 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 Amanitin as
Slide 5: Management Team with Strong Pharma and R&D Experience
Management Team with Strong Pharma and R&D Experience Dr. Jan Schmidt-Brand Prof. Dr. Andreas Pahl CEO / CFO CSO @ Heidelberg Pharma since 2001 @ Heidelberg Pharma since 2012 30 years’ experience in commercial and financial leadership positions in pharma Professor of Pharmacology and Toxicology at t
Slide 6: Strategic Cornerstones
Strategic Cornerstones Build proprietary ATAC Licensed legacy assets ATAC pipeline collaborations (non-ATACs) HDP-101 – ATAC targeted against Licensing collaborations with Additional upside potential BCMA (multiple myeloma) pharma and biotech from clinical programs TLX250-CDx – diagnostic imaging ag
Slide 7: 2020 Company Highlights
2020 Company Highlights R&D Highlights Corporate & Financial Highlights Lead candidate HDP-101 • Heidelberg Pharma receives milestone payment from Magenta for MGTA-117 (Sep) • GLP toxicity study with HDP-101 completed (Jul) • Contract extension with Takeda for ATAC-collaboration by 1 year • Meeting
Slide 8: Proprietary ATAC Projects Update
Corporate Overview & Highlights Proprietary ATAC projects Update Partnered projects Update Financials & Financing Outlook © Heidelberg Pharma AG 8
Slide 9: ATACs Offer a Range of Clinical Benefits with Best-in-Class Potential
ATACs Offer a Range of Clinical Benefits with Best-in-Class Potential Unique preclinical features of ATACs Potential clinical benefit Efficacious on dormant tumor cells Longer PFS and MRD negativity Efficacious in tumor cells with ultra-low target expression Deeper responses and higher ORR Novel MoA
Slide 10: ATACs Exhibit Synergy with Immune Checkpoint Inhibitors
ATACs Exhibit Synergy with Immune Checkpoint Inhibitors C57BL76-Tg(WapHER2) mice orthotopically implanted with HER2-low EO771 cells with 11B loss Tumor growth curve Survival analysis Sci. Transl. Med. 13 (2021) HER2-ATAC potentiates immune checkpoint blockade therapy in treating HER2-low Breast Canc
Slide 11: 17p Deletion as Potential Predictive Biomarker
17p Deletion as Potential Predictive Biomarker Co-deletion of TP53/POLR2A Genes MD Anderson Cancer Center and Heidelberg Pharma collaboration Biomarker approach for multiple tumor entities 17p deletion associated with more aggressive tumors Deletion of TP53 gene with frequent co-deletion of nearby R
Slide 12: Multiple Myeloma Major Unmet Medical Need
Multiple Myeloma Major Unmet Medical Need • Second most prevalent hematopoietic malignancy* • 70,000 deaths due to MM annually; median age at diagnosis is 65-70 years • Characterized by the proliferation of single clone of plasma cells derived from B-cells which produce abnormal antibodies • Current
Slide 13: HDP-101 Development Activities
HDP-101 Development Activities Activity Status Long-term stability studies of HDP-101 Ongoing Contracts with the study centers in the US and GER Partially completed Investigational New Drug (IND) allowance from FDA for the US Completed Submission of the Clinical Trial Application (Germany) Completed
Slide 14: HDP-101-01 Clinical Trial Study Scheme
HDP-101-01 Clinical Trial 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 • Up to 30 patients with RRMM myeloma (RRMM) • Biomarker stratifica
Slide 15: New ATAC Candidates: HDP-102 and HDP-103
New ATAC Candidates: HDP-102 and HDP-103 HDP-102: CD37-ATAC • CD37 is overexpressed on B-cell lymphoma cells • Specific indication of non-Hodgkin lymphoma (NHL) • High prevalence of 17p deletion in NHL • Antibody and payload manufacturing ongoing HDP-103: PSMA-ATAC • PSMA is overexpressed in nearly
Slide 16: Partnered Projects Update
Corporate Overview & Highlights Proprietary ATAC projects Update Partnered projects Update Financials & Financing Outlook © Heidelberg Pharma AG 16
Slide 17: Partner Magenta Making Important Progress in ATAC Programs
Partner Magenta Making Important Progress in ATAC Programs for Conditioning MGTA-117 – ATAC against CD117 ATAC against CD45 Antibody-drug conjugate (ADC) for depletion of hematopoietic stem CD45-ADC targets both patient HSCs and disease-causing immune cells and progenitor cells in the bone marrow •
Slide 18: Partner Telix – Next Steps with TLX250-CDx and TLX250
Partner Telix – Next Steps with TLX250-CDx and Therapeutic Agent TLX250 TLX250-CDx – diagnostic imaging agent TLX250 – therapeutic agent TLX250-CDx – 89Zirconium-labeled antibody girentuximab TLX250 - 177Lutetium-labeled antibody girentuximab: ZIRCON Phase III trial ongoing: Therapeutic radioimmunoc
Slide 19: Partner RedHill – RHB-107 Evaluation in COVID-19 Ongoing
Partner RedHill – RHB-107 (upamostat) Evaluation in COVID-19 Ongoing RHB-107 – serine protease inhibitor • Potential first-in-class small molecule targeting cancer, inflammatory lung diseases, and gastrointestinal diseases • So far: Positive Phase II trials in pancreatic and breast cancer (WILEX AG)
Slide 20: Financials & Financing
Corporate Overview & Highlights Proprietary ATAC projects Update Partnered projects Update Financials & Financing Outlook © Heidelberg Pharma AG 20
Slide 21: Profit and Loss 2020
Profit and Loss 2020 in € m Guidance FYR 2020 FYR 2019 Change Sales revenue and other income 9.0 – 10.0 9.6 8.0 20% Operating expenses 26.0 – 28.0 27.9 18.1 54% Cost of sales 5.6 3.7 51% Operating expenses 1% R&D costs 18.3 10.9 68% 13% 20% Administrative costs 3.6 3.2 12% Other expenses 0.4 0.3 33%
Slide 22: Balance Sheet and Cash 2020
Balance Sheet and Cash 2020 Assets (€ m) 30.11.2020 30.11.2019 Equity and liabilities (€ m) 30.11.2020 30.11.2019 Non-current assets 12.1 11.4 Current liabilities 6.6 6.5 Other current assets 2.5 1.7 Non-current liabilities 0.1 0.2 Cash and cash equivalents 5.0 9.9 Equity 12.9 16.3 19.6 23.00 19.6 2
Slide 23: Guidance 2021
Guidance 2021 in € m Actual 2020 Guidance 2021 Sales revenue and other income 9.6 5.5 to 7.5 Operating expenses 27.9 36.0 to 40.0 R&D costs 18.3 - Operating result (EBIT) (18.3) (30.0) to (34.0) Funds required 19.2 30.0 to 34.0 Funds required per month 1.6 2.5 to 2.8 2021 • Sales revenue: • Lower am
Slide 24: Shares
Shares Shares Share performance • High: €9.30 (16 March 2020) Heidelberg Pharma AG Nasdaq Biotech Index • Low: €2.06 (02 January 2020) DAX Sub All Biotechnology • Shares outstanding: 31,061,872 (as of 30 November 2020) 450 • Average daily trading volume: ~40,000 shares (all stock exchanges, ytd) 400
Slide 25: Outlook
Corporate Overview & Highlights Proprietary ATAC projects Update Partnered projects Update Financials & Financing Outlook © Heidelberg Pharma AG 25
Slide 26: Operational Outlook
Operational Outlook ATAC technology HDP-101 – next steps planned • Initiation of clinical study in Germany after approval of CTA • Site activation & First Patient In in the US and Germany • 17p biomarker validation Proprietary pipeline • HDP-102 & HDP-103 to advance as next proprietary development c
Slide 27: Investment Summary
Investment Summary Disruptive first-in-humans mode of action provides high efficacy and potential for unique clinical advantages, including treatment of dormant tumor cells Increased efficacy against 17p deleted and aggressive tumor cells based on biomarker Validated by high quality collaborations (
Slide 28: Contact Us
Contact Us Upcoming conferences & events Venue Date BIO Europe Spring Virtually delivered 22 – 25 March 2021 Spring Meeting Oncology Investor Conference 2021 Virtually delivered 30 March – 2 April 2021 European Biotech Investor Days 2021 Virtually delivered 7 – 8 April 2021 AACR Annual Meeting 2021