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ATACs fighting CancerMarch 21, 2019FY 2018 Financial Results & Business Update
2© Heidelberg Pharma AG
Safe Harbor
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 similar expressions or by general discussion of strategy, plans or intentions of the Company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Such factors include, among others, the following: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of
Forward looking statementsadditional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication.
Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.
This material is not intended as an offer or solicitation for the purchase or sale of shares of Heidelberg Pharma AG. This material may not be distributed within countries where it may violate applicable law.
3
Corporate Overview & Highlights
Projects Update
Financials & Financing
Outlook
© Heidelberg Pharma AG
Heidelberg Pharma at a Glance
Our Company Our Mission Our Approach
Listed as Heidelberg Pharma AGFrankfurt Stock Exchange: WL6
Shares outstanding: 28.13 million
Market cap: ~€90 million
Headquarters: Ladenburg, Germany
66 employees
Improve efficacy
Overcome resistance mechanisms
Kill dormant tumor cells
Provide new options in cancer therapy
New mode of action in cancer therapy - Antibody Targeted Amanitin Conjugates (ATACs)
• Induction of apoptosis by inhibition of RNA Polymerase II
• Application of innovative payload by harnessing ADC therapeutic modality
© Heidelberg Pharma AG 4
Developing new options to address major challenges in cancer therapy
Strategic Cornerstones
ATAC technology
partner
Clinical assets
ATAC collaboration
& pipeline
Lead ATAC HDP-101
Proprietary lead candidateHDP-101
ATAC third-party collaborations + other proprietary ATAC candidates
ATAC technology partnering with pharma and biotech
MESUPRON® (RedHill, Link Health)
REDECTANE® (Telix)
RENCAREX®
© Heidelberg Pharma AG 5
Build proprietary ATAC pipeline
Sign technology licensing collaborations
Additional upside potential with partnered non-ATAC
legacy clinical assets
Achievements - Last 12 Months
© Heidelberg Pharma AG 6
Proprietary ATAC Project ATAC Technology Licensing Licensed Projects
Development HDP-101• Amanitin GMP transfer Amanitin
synthesis• BCMA Antibody GMP material
• Regulatory path Type C Meeting FDA Scientific Advice Paul-Ehrlich
Institute• Scientific conferences Poster at AACR (4/2018) Oral presentation by MD
Anderson at ASH (12/2018)
• TLX250-CDx – Imaging agent for Renal Cancer with PET/CT Global ZIRCON Phase III trial
started in Europe and Australia ZIR-DOSE clinical study patient
enrolment completed
• MESUPRON® Link Health received IND
approval to conduct clinical trials in China
• Multi-Target Research and Option Agreement Deal signed in 3/2018:
totaling up to more than USD 330 million for up to four potential targets
1st licensing option exercised 10/2018
• ASH Conference 12/2018: 3 poster
presentations
7© Heidelberg Pharma AG
ATACs – Growing Pipeline of Proprietary and Partnered Programs
Product Target Indication Research Preclinic Clinic Partner
Proprietary I II III
HDP-101 BCMA Multiple myeloma (DLBCL/CLL) Proprietary
PSMA-ATAC PSMA Prostate cancer Proprietary
CD19-ATAC CD19 Hematological tumors Proprietary
XX-ATACs n/a Leukemias & solid tumors Undisclosed partners
ATAC technology partner
TAK-XX-ATACs n/a n/a Takeda/ Millennium
MGTA-XX-ATACs CD117, CD45
HSCs, Conditioning programs for bone marrow transplant in AML Magenta
• Despite positive data, the R&D collaborations with MabVax (2015) and Nordic Nanovector (2016) have been terminated 2018 due to differences in interests
8
Corporate Overview & Highlights
Projects Update
Financials & Financing
Outlook
© Heidelberg Pharma AG
9© Heidelberg Pharma AG
Lead Proprietary ATAC Candidate HDP-101 –Strong Case for Multiple Myeloma
• Amatoxin + Linker + BCMA antibody = HDP-101• Ideal for multiple myeloma (MM) treatment
• MM is still considered incurable, median survival of ~30-60 months
• Current treatment options: Chemotherapy, immuno-modulatory drugs, proteasome inhibitors and autologous stem cell transplantation (ASCT)
• BCMA expression highly restricted in MM, a mature B-cell neoplasm, and malignant CLL/DLBCL
• Hematological tumor type = good accessibility to tumor cells• Additional indications: Diffuse large B-cell lymphoma (DLBCL) and
chronic lymphocytic leukemia (CLL)
BCMA ideal target for an ATAC approach, validated through CAR-Ts
Death cap mushroom
BCMA ATAC = HDP-101
Chemical synthesis
BCMA antibody
10
Biomarker Applies to HDP-101 in Multiple Myeloma
Oral Presentation at the ASH 60th Annual Meeting Dec. 2018 in San DiegoThe University of Texas MD Anderson Cancer Center and Heidelberg Pharma AG:
Translates basic findings from 2015 Nature article to Multiple Myeloma
© Heidelberg Pharma AG
HDP-101 is active against MM with Preferential Efficacy Against Preclinical Models of Deletion 17p
Biomarker RNA pol IIPotential to expedite clinical development
• Multiple Myeloma patients with 17p deleted tumors have a very highmedical need for new treatment options
• HDP-101 has a preferential activity on 17p deleted tumor cells derived from Multiple Myeloma patients (ASH conference 2018)
• Potential options to speed-up market approval for such a selected patient population if preclinical data translate into clinical benefits
• Potentially broader therapeutic window resulting in lower development risk and new treatment option for patient segment with bad prognosis
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17p Deletion: Clinical Hypothesis and Possible Implications for HDP-101
© Heidelberg Pharma AG
Possible development implications for HDP-101
Solid Progress in Establishing Manufacturing Processes to Produce GMP Material
The world’s first and so far only industrial source of chemically produced Amanitin
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I: Antibody
Cell line development
Master cell bank
Pre GMP material antibody
GMP material antibody
II: Toxin/Linker
Synthesis
Technical transferAmanitin/linker
Pre GMP material Amanitin/linker
GMP material HDP 30.2115
III: HDP-101 Drug Substance
Technical transfer and scalingHDP-101
Pre GMP (tox) material HDP-101
GMP material HDP-101
IV: HDP-101 Drug Product
Lyophilization dev
Technical batch
Fill & Finish
ongoing activity
completed
in preparation
Partner Magenta: Advancing CD117 & CD45 ATACs
13Copy right: Magenta 2018
Magenta exercised option to further develop CD117 ATAC (C200) in October 2018
14
Corporate Overview & Highlights
Projects Update
Financials & Financing
Outlook
© Heidelberg Pharma AG
in € m Guidance 03/2018
Revised Guidance 10/2018 Actual 2018
Sales revenue and other income 3.0 to 5.0 3.5 to 4.5 4.4
Operating expenses 16.0 to 20.0 14.0 to 16.0 16.0
Operating result (EBIT) -12.0 to -16.0 -10.0 to -12.0 -11.7
Funds required 13.0 to 17.0 10.0 to 13.0 10.9
Funds required per month 1.1 to 1.4 0.8 to 1.1 0.9
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Financial Review 2018
• Guidance revised due to cost postponements into the following year; resulting in lower operating expenses• Sales revenues nearly doubled
Financing• Cash at the end of 2018 financial year: €19.4 m• Cash reach is secured until mid 2020 based on current budget planning
© Heidelberg Pharma AG
Profit and Loss 2018
16
14%
67%
18%
1%
Cost of salesR&D costsAdministrative costsOther expenses
• Sales revenue nearly doubled due to increased ATAC collaborations; Other income slightly up because of milestone payment to the mother company
• Expansion of cost-intensive external GMP production of HDP-101 increased R&D costs
(€ m) FY 2018 FY 2017 Change
Sales revenue 3.7 1.9 95%Other income 0.7 0.6 17%
Income 4.4 2.5 76%Cost of sales 2.2 1.0 120%R&D costs 10.7 9.3 15%Administrative costs 2.9 2.7 7%Other expenses 0.2 0.2 -
Operating expenses 16.0 13.2 21%Net loss for the period 11.7 11.0 6%
Operating expenses
Balance Sheet and Cash Flow 2018
• Average cash usage per month €0.9 m (2017: €0.7 m)• Cash reach until mid 2020
17
• Cash balance at November 30, 2018: €19.4 m (2017: €30.4 m)• Equity year-end 2018 decreased to €25.9 m• Equity ratio was 83.0% (2017: 89.2%)
Assets (€ m) 30.11.2018 30.11.2017
Non-current assets 10.9 10.3
Other current assets 0.9 0.8
Cash and cash equivalents 19.4 30.4
31.2 41.5
Equity and liabilities (€ m) 30.11.2018 30.11.2017
Current liabilities 5.3 4.5
Non-current liabilities 0.0 0.0
Equity 25.9 37.0
31.2 41.5
Cashflow (€ m) 30.11.2018 30.11.2017
Operating cash flow -10.00 -7.9
Investing cash flow -1.0 -0.4
Financing cash flow 0 34.2
Exchange rate effects 0.04 -0.02
Net cash change -10.9 25.8
Dietmar Hopp and affiliated
companies**
75%
UCB4%
Freefloat20%
Corporate bodies *
1%
18© Heidelberg Pharma AG
Heidelberg Pharma Shares
* held directly** dievini Hopp BioTech holding GmbH & Co. KG +
DH Holding Verwaltungs GmbH
• High: €3.980 (15 January 2018)
• Low: €1.880 (11 October 2018)
• Daily trading volume: 26,125 shares (FY 2017: 14,049)
• Shares outstanding: 28,143,860 (as of 28 February 2019)
• Current market cap: ~€90 m (March 2019, € 3.20)
Share performance 2018 Share ownership as of 28 February 2019
• Pareto 12/18: target €3.70
• Baader Helvea 10/18: target €4.40
• EQUI.TS 10/18: target €5.02
Analyst coverage
19
Corporate Overview & Highlights
Projects Update
Financials & Financing
Outlook
© Heidelberg Pharma AG
20© Heidelberg Pharma AG
Next Steps and Potential Milestones
REDECTANE® (Telix)TLX250-CDx – imaging agent• ZIRCON Phase III trial – enrollment
of 250 patients, sites to be added in the US and Canada (subject to regulator approval)
• Complete ZIR-DOSE bridging studyTLX250 - 177Lu-girentuximab• Combination trials with therapeutic
radioimmunoconjugate & check-point inhibitor immunotherapy in the US (subject to FDA approval)
MESUPRON® (Link Health)• Revise development plan for China
based on new NMPA regulations
Partnered legacy clinical programs
• HDP-101• Conduct final GLP toxicity study in monkeys• Draft study protocol, sign contracts with trial centers • Manufacture GMP material for clinical trials• Submit application to regulatory authorities in USA and
Germany to conduct a Phase I trial• Gain IND and CTA approval to conduct a Phase I trial • Open clinical trial centers, including approvals by ethics
commissions• Develop biomarker
• Select next proprietary development candidate• Sign additional license and collaboration agreements• Reach next milestones with existing partners
ATAC technology and proprietary pipeline
21
Financial Guidance 2019
In € m FY 2018 Guidance FY 2019
Sales revenue and other income 4.4 5.0 to 7.0
Operating expenses 16.0 14.0 to 18.0
Operating result (EBIT) -11.7 -8.0 to -12.0
Funds required 10.9* 10.0 to 14.0
Funds required per month 0.9* 0.9 to 1.2
• Cash reach until mid 2020 based on the current development plan and financial planning
* Excluding capital increases and loan
22© Heidelberg Pharma AG
Investment Summary
Developing new options to address major challenges in cancer therapy
• Heidelberg Pharma is developing new treatment options with Amanitin for different cancer indications, also validated by high-quality collaborations
• Innovative first-in-humans mode of action provides strong efficacy and potential for unique clinical advantages including killing of dormant tumor
• Especially effective on tumors with 17p deletion, particularly aggressive form of MM• Value step-up ahead due to transition to clinical stage of lead product HDP-101 in multiple myeloma• Dual business model – early validation and cash through pharma collaborations + future high value
potential with proprietary portfolio
AA
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Upcoming conferences and events
Financial Calendar Date
Q1 – Interim Results April 11, 2019
Annual General Meeting May 21, 2019
Half-year Financial Results July 11, 2019
Q3 – Interim Results October 10, 2019
Upcoming conferences & events H1 2019 Venue Date
BIO-Europe Spring Vienna 25 – 27 March 2019
AACR Annual Meeting Atlanta 29 March – 3 April 2019
Deutsche Biotechnologietage Würzburg 9 – 10 April 2019
Annual General Meeting Heidelberg 21 May 2019
ASCO Annual Meeting 2019 Chicago 31 May – 4 June 2019
World ADC Asia 2019 Shanghai 11 - 13 June 2019
Next Generation Protein Therapeutics & Bioconjugates Summit San Francisco 18 – 20 June 2019
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Contact Us
Heidelberg Pharma AG
Schriesheimer Strasse 10168526 Ladenburg, GermanyTel.: +49 6203 1009-0Fax: +49 6203 1009-19Website: www.heidelberg-pharma.com
IR/PR support
MC Services AGKatja Arnold (CIRO)Tel.: +49 89 210 288-40Email: katja.arnold[at]mc-services.eu
Ticker data
ISIN: DE000A11QVV0 Symbol: WL6 Reuters: WL6G.DE Bloomberg: WL6.GR
© Heidelberg Pharma AG