atacs fighting cancer - heidelberg-pharma.com · atacs fighting cancer march 21, 2019 fy 2018...

ATACs fighting CancerMarch 21, 2019FY 2018 Financial Results & Business Update

2© Heidelberg Pharma AG

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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.

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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®


Build proprietary ATAC pipeline

Sign technology licensing collaborations

Additional upside potential with partnered non-ATAC

legacy clinical assets

Achievements - Last 12 Months


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


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

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Projects Update


Outlook



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

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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


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


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

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Projects Update


Outlook


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


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

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• 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%


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


Projects Update


Outlook



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

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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


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


atacs fighting cancer - heidelberg-pharma.com · atacs fighting cancer march 21, 2019 fy 2018...

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