Post on 07-Oct-2020
Company Update
November 2012
© MorphoSys - November 2012
Safe Harbour
© MorphoSys - November 2012
This presentation includes forward-looking statements.
Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing.
These and other risks and uncertainties are detailed in the Company’s Annual Report.
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Components of the Business
© MorphoSys - November 2012
Technology-driven Alliances
Proven HuCAL platform
Ylanthia launched
Collaboration with Lanthio Pharma
Innovative Product Pipeline
MOR103 shows excellent safety and efficacy in RA
Partner Phase 2 read-outs coming
21 clinical programs
AbD Serotec
Emerging diagnostics business
Research antibody catalog
Financially Strong
Sustainably cash-flow positive
Strong balance sheet
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Pipeline Gathering Momentum
© MorphoSys - November 2012
MOR103
Excellent clinical proof-of-concept and safety data generated in rheumatoid arthritis Phase 1b/2a trial
MOR208
Positive safety and efficacy data from Phase 1/2a trial in CLL/SLL
Gantenerumab
Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche
Solanezumab results provide support for Roche trial design
Selected by Dominantly-Inherited Alzheimer Network (DIAN) for world-wide trial in early-onset AD
CNTO1959
Janssen commences Phase 2 RA comparison study with Stelara®
BYM338
Novartis completes Phase 2 study in sporadic inclusion body myositis
OMP-59R5
Oncomed commences Phase 1b/2 trial in first-line advanced pancreatic cancer
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Innovative Product Pipeline
© MorphoSys - November 2012 5
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3Gantenerumab Roche Amyloid-ß Alzheimer’s DiseaseMOR103 (2 programs) - GM-CSF Rheumatoid Arthritis
Multiple sclerosisCNTO888 Janssen/J&J MCP-1 (CCL-2) IPFCNTO1959(2 programs) Janssen/J&J IL23p19 Psoriasis
RABHQ880 Novartis DKK-1 CancerBYM338 Novartis - MusculoskeletalNOV – 3 Novartis - not discl.NOV – 4 Novartis - OphthalmologyOMP-59R5 OncoMed/GSK Notch 2 CancerMOR208 - CD19 CLLMOR202 - CD38 MMBAY94-9343 Bayer Healthcare Mesothelin (ADC) CancerBI – 1 BI - not discl.CNTO3157 Janssen/J&J - AsthmaCNTO – 5 Janssen/J&J - InflammationNOV – 5 Novartis - InflammationNOV – 6 Novartis - CancerOMP-18R5 OncoMed/Bayer Fzd 7 CancerPFE – 1 Pfizer - Cancer
21 Programs Various Partners - Various Indications
34 Programs Various Partners - Various Indications
76 Therapeutic Antibody Programs21 Programs in Clinical Development
© MorphoSys - November 2012
70 Partnered Programs6 Proprietary Programs
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MOR103A Novel Anti-Inflammatory Antibody
© MorphoSys - November 2012
Large Market and Unmet Need in Rheumatoid Arthritis
Approved biologics, mostly anti-TNF therapies, generate $20bn in annual sales
30-40% of patients do not adequately respond to anti-TNFs
50% of responders stop responding within 2 years
MOR103
Ultra-high affinity HuCAL IgG1 targeting GM-CSF
Potential for superior efficacy and better safety than current treatments
Intellectual Property
Exclusive license to a US patent covering anti-GM-CSF antibodies for the treatment of chronic inflammatory conditions
US patent on MOR103 composition of matter
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MOR103Phase 1b/2a Trial in Rheumatoid Arthritis
© MorphoSys - November 2012
Trial design
96 patients with active, mild-to-moderate RA (DAS28≤5.1)
Randomized, double-blind, placebo-controlled
Dose regimen: 0.3, 1.0 and 1.5 mg/kg weekly x 4 injected intravenously vs. placebo
26 sites in Holland, Germany, Poland, Bulgaria & Ukraine
Primary outcome measures
Adverse event rate and safety profile
Secondary outcome measures
DAS28, ACR core set measures and EULAR28 response criteria, MRI (synovitis & bone edema), patient reported outcomes at 4 and 8 weeks
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7.4
25.0
68.2
30.4
0
10
20
30
40
50
60
70
80
Week 4
Placebo
MOR103 0.3mg/kg
MOR103 1.0mg/kg
MOR103 1.5mg/kg
MOR103 Shows Impressive Efficacy & Fast Onset of Action
© MorphoSys - November 2012
ACR20 Response at week 4 (FAS population)
% o
f pa
tien
ts
FAS: Full Analysis Set, N= 96
p<0.0001
ACR20 ranks amongst highest observed for a biologic in RA after 4 weeks
Very fast onset of therapeutic effect within 2 weeks
Robust and durable responses 10 weeks beyond treatment
Imaging confirms anti-inflammatory activity
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ACR20 Scores Compare Favorably to Other Biological DMARDs
© MorphoSys - November 2012
0
10
20
30
40
50
60
70
0 1 2 3 4
Placebo
MOR103 1 mg/kg
MOR103 1.5 mg/kg
mavrilimumab
adalimumab
abatacept
tocilizumab in TNF-IR
Time (weeks)
% o
f pa
tien
ts
ACR20 Response over 4 weeks*
Level of efficacy and speed of onset exceed those seen for mavrilimumab, adalimumab (Humira), abatacept (Orencia) and tocilizumab (Actemra)
* Data from separate clinical studies
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MOR103Safe & Well-tolerated at All Doses
© MorphoSys - November 2012
Serious Adverse Events (SAEs)
No treatment-related SAEs in the active treatment groups
Related adverse events (AEs)
More frequent in placebo group (25.9%) than in active treatment group (14.5%)
Most common AEs (≥6%) were nasopharyngitis, RA flare, fatigue and hypertension
Majority of AEs were of mild intensity
One patient on placebo discontinued treatment due to an AE
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MOR103Looking Ahead
© MorphoSys - November 2012
Rheumatoid arthritis
Expect even higher efficacy on− longer treatment− development in moderate to severe patients
Potential for dosing monthly or even less frequently
Multiple sclerosis
Phase 1b study in MS patients ongoing
GM-CSF is the only non-redundant inflammatory cytokine in EAE
Major unmet need in progressive forms of the disease
Sub-cutaneous formulation
Phase 1 study in healthy volunteers confirms feasibility of subcutaneous administration
Partnering
Discussions ongoing
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MOR208 (XmAb5574)A Novel Anti-Cancer Antibody
© MorphoSys - November 2012
Large Market and Unmet Need
High unmet medical need in NHL, CLL & ALL
Revenues with approved drugs for B cell malignancies exceed $5bn
Relapsing patients have limited treatment options
Phase 2 data for blinatumomab validate CD19 as target for B-cell malignancies
MOR208
Humanized, high affinity anti-CD19 antibody
Exclusive license from Xencor
Antibody comprises a proprietary Xencor modification of the Fc part of the antibody leading to rapid and sustained B-cell depletion
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MOR208 Has Compelling Prospects
© MorphoSys - November 2012
MOR208 Has An Attractive Competitive Profile
Expect convenient dosing schedule
Straightforward manufacturing
Potential for good safety profile
Significantly increased ADCC compared to unmodified antibody
Clinical Development
Preclinical data show synergistic effects on target cell killing in combination therapies with existing drugs
Phase 1, in relapsed or refractory CLL/SLL patients, to be presented at ASH 2012:
− Favorable safety profile
− 3/27 partial responses and 22/27 patients with stable disease
− Results from trial extension expected in Q1 2013
Phase 2: Trials in B cell malignancies starting Q4 2012
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MOR202A Novel Antibody for Multiple Myeloma
© MorphoSys - November 2012
Large Market and Unmet Need
Revenues with approved drugs in MM exceed $2bn, but median survival is only 3-5 years
MOR202
High affinity HuCAL antibody targeting CD38
Competitive Profile
Preclinical data show strong synergy in combinations of MOR202 with Velcade or Revlimid
New pre-clinical data to be presented at ASH
Clinical Development
Phase 1, in relapsed or refractory MM patients ongoing
Phase 2a, monotherapy extension
Phase 1b, MOR202 + Velcade
Phase 1b, MOR202 + Revlimid
Up to 82 patients, at sites in Germany and Austria
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Gantenerumab: A HuCAL Antibody Being Developed by Roche for Alzheimer’s Disease
© MorphoSys - November 2012
Large Market and Unmet Need
Alzheimer’s disease is estimated to affect 25 million people worldwide
Increasing with aging population
Once symptoms for AD dementia have appeared, it may be too late to treat
Picture: Courtesy of Roche
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Gantenerumab is the Most Advanced Antibody in Prodromal AD Patients
© MorphoSys - November 2012
Gantenerumab
High affinity HuCAL antibody targeting amyloid-β
Binds & breaks down amyloid-β fibrils and plaques
Clinical Development
Phase 1, in patients completed
− Gantenerumab reduces brain amyloid 3x faster than other amyloid-targeting substances
Potentially pivotal Phase 3 study ongoing
− 770 prodromal patients, 2 doses, placebo-controlled
− 104 weeks on drug
− CDR-SOB, ADAS-COG, change in brain amyloid
− Initial data expected in 2015: favorable outcome could support a marketing application
Data from Phase 1Effect of gantenerumab on
amyloid load as indexed by PET SUVR at end of treatment
% Am
yloi
d ch
ange
from
bas
elin
e
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Technology-driven Alliances
© MorphoSys - November 2012 18
Proprietary Technology Platform Underpins Lucrative Alliances
© MorphoSys - November 2012
MorphoSys has successfully partnered its human antibody technology HuCAL with many of the leading pharmaceutical companies
Lucrative model
− Makes MOR cash-flow positive
− Funds proprietary R&D
− Future upside from milestones & royalties
MorphoSys Pharma partner
Target
HuCAL antibody drug candidate
R&D fundingTechnology licence feesMilestones and royalties
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Commercial Launch of Ylanthia
© MorphoSys - November 2012
Slonomics
Best technology for protein libraries secured in Sloning acquisition
Deals have already paid for acquisition− Pfizer, Novozymes, unnamed pharma
Ylanthia
Totally new antibody platform
Higher quality antibodies, greater diversity faster lead generation
Opens new opportunities
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New technologies now part of expanded Novartis strategic alliance
Novartis committed through 2017 with annual license fees, FTE funding, milestones, royalties
MOR free to partner platform broadly
Technology Alliance on New Class of Therapeutic Peptides
© MorphoSys - November 2012 21
MorphoSys and Lanthio Pharma Sign Technology Alliance on New Class of Therapeutic Peptides Lanthio Pharma is focused on discovering and developing
lantipeptides (constrained peptides) Lantipeptides comprise a novel class of therapeutics
with high target selectivity and improved drug-like properties
The companies will jointly apply their respective technologies to establish high quality and diverse lantipeptide-based libraries
Peptides: Where‘s the Niche? Constrained peptides can be positioned between small
molecules and biological drugs
First transaction combining collaborative aspects and a corporate VC-like investment
Lanthio Pharma Groningen,
Holland Founded:
2010
Series A financing: BioGeneration
Ventures INKEF Capital MorphoSys Hanzepoort
AbD Serotec
© MorphoSys - November 2012 22
AbD Serotec Segment Complements Therapeutic Business
© MorphoSys - November 2012
Catalogue of 15,000+ products
Stable and recurring cash flows
Customers comprise universities, government bodies, life science companies
Website, eCommerce
Custom antibody generation
Using proprietary technologies to deliver superior Dx antibodies
Future upside via royalties
Working with over 20 Dx companies
HuCAL – Diagnostic ApplicationsResearch Activities
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Strong Financials
© MorphoSys - November 2012 24
Key Financials
© MorphoSys - November 2012
in € million 2011 Guidance 2012* 9M 2012
Group Revenues 100.8 70 – 75 48.9
Total Operating Expenses 89.1 51.3
COGS 7.0 4.8
Funded R&D 20.7 13.1
Proprietary R&D (incl. technology development) 36.8 20 – 25 17.2
Sales, General & Administrative Expenses 24.6 16.2
EBIT 10.1 1 – 5 (2.3)
Cash & Marketable Securities and Interest-bearing Assignable Loans (at end of period) 134.4 137.5
* as of Nov 7, 2012
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Shareholdings
© MorphoSys - November 2012
Shares issued: 23,308,622 (September 30, 2012)
Treasury stock: 255,415 (September 30, 2012)
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Forthcoming Pipeline Developments
© MorphoSys - November 2012
Proprietary Portfolio
MOR103 phase 1b/2a data at ACR 2012 (November)
MOR208 phase 1 data at ASH 2012 (December)
MOR208 data from extended dose group (Q1 2013)
MOR202 interim data from phase 1 open label study
Partnered Pipeline*
Several Phase 2 studies to complete shortly
− BHQ880 (Novartis, oncology to be presented at ASH)
− CNTO888 (Janssen Biotech, IPF)
− BYM338 (Novartis, musculoskeletal diseases)
− NOV-3 (n.d.)
− NOV-4 (ophthalmology)
Roche hints at interim analysis of gantenerumab Phase 3 study during 2013
* MorphoSys estimates based on publicly-available information
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Appendix
© MorphoSys - November 2012
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® , Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
Dr. Claudia Gutjahr-LöserHead of Corporate Communications & IR
Phone +49 (0)89 / 899 27-122Fax +49 (0)89 / 899 27-5122Email investors@morphosys.com
Thank You
www.morphosys.com